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Australian Clinical Trials

Search results from the Australian New Zealand Clinical Trials Registry

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Keyword: garvan
Recruitment Status: Recruiting

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A surveillance study investigating whole body magnetic resonance imaging and other diagnostic procedures in people at high risk of cancer

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Trial Information

Trial summary

The study is investigating whole body magnetic resonance imaging (MRI) and other diagnostic procedures in people at high risk of cancer. Who is it for? You may be eligible to join this study if you are aged between 18-70 years, and are a known NF1 patient, OR a known cancer risk gene mutation carrier, OR have a family member at 50% risk of carrying a mutation. You will not be eligible if you have an active cancer diagnosis. Study details - All participants in this study will have an initial clinical review followed by annual diagnostic procedures for a period of 3 years. This may include annual whole body MRI scans, breast MRI (females only), fecal occult blood test and full blood count. Additional investigations including colonoscopy and upper gastrointestinal endoscopy may also be conducted at varying time points, as indicated by family history and clinical appropriateness. Participants will also be asked to complete psychosocial questionnaires and invited to participate in in-depth interviews. This study will provide estimates of the prevalence and incidence of investigable lesions, and the acceptability, safety, psychosocial impact, and cost-effectiveness of the screening protocol. This information will be used to design a large scale screening project.

Broad Health ConditionCancer

Specific Health ConditionCancer
Any cancer

Trial FocusDiagnosis

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Monash Medical Centre - Clayton campus - Clayton

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Hospital
Prince of Wales Hospital - Randwick

Hospital
Peter MacCallum Cancer Centre - Melbourne

Hospital
The Royal Adelaide Hospital - Adelaide

Postcode
3168 - Clayton

Postcode
2010 - Darlinghurst

Postcode
2031 - Randwick

Postcode
3000 - Melbourne

Postcode
5000 - Adelaide

Anticipated date of first participant enrolment9/07/2013

Anticipated date of last participant enrolment1/09/2026

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Known cancer risk gene pathogenic mutation carrier or family member at 50% risk of carrying a mutation
ECOG performance status 0 or 1
No active cancer diagnosis. This is defined as the primary tumour having been treated
with no clinical or symptomatic evidence of metastatic disease
Expected lifespan greater than 3 years

Minimum age18 Years

Maximum age70 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Inability to provide informed consent
Serious co-morbid illness
Active cancer diagnosis
Inability to undergo study procedures
Inability to understand an English language consent form
Pregnancy
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australasian Sarcoma Study Group
Primary Sponsor Address: Peter MacCallum Cancer Centre 305 Grattan Street Melbourne Victoria 3000
Primary Sponsor Country: Australia

Trial IDACTRN12613000987763

Contact person for information and recruitmentDr
Mandy Ballinger
The Kinghorn Cancer Centre, Garvan Institute of Medical Research, 370 Victoria Street, Darlinghurst, NSW 2010
+61 2 9355 5806
+61 2 9355 5872
Further information iconm.ballinger@garvan.org.au
Australia

The neuroendocrine and metabolic effects of oestrogens

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Trial Information

Trial summary

The purpose of this study is to understand how oestrogen controls the use of fat in the liver. The hypothesis is that oestrogen is required to prevent the accumulation of fat in the liver. The mechanism may be direct or mediated by other hormones such as growth hormone, which is regulated by oestrogen. 
We wish to study the effects of oestrogen compounds called Selective Oestrogen Receptor Modulators (tamoxifen) and a drug that prevents oestrogen production (letrozole) on the secretion of growth hormone from the special gland in brain and how they control the liver production and burning of fat in men and women. We wish to compare these effects with that of natural oestrogen itself in women.

Broad Health ConditionNeuroendocrine regulation of GH secretion by oestrogens
Metabolic effects of oestrogens

Specific Health ConditionMetabolic and Endocrine
Normal metabolism and endocrine development and function

Trial FocusTreatment

Recruitment statusRecruiting

Anticipated date of first participant enrolment3/08/2010

Phase of TrialPhase 4

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Healthy postmenopausal women and men the same age
BMI <25 kg/m2

Minimum age50 Years

Maximum age70 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

History of liver, kidney diseases, cancer, diabetes, endocrine disorders, that are likely to interfere with the metabolism or excretion of the test medication.
Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Garvan Institute of Medical Research
Primary Sponsor Address: 384 Victoria St Darlinghurst 2010 NSW
Primary Sponsor Country: Australia

Trial IDACTRN12611001093976

Contact person for information and recruitment
Vita Birzniece
Garvan Institute of Medical Research 384 Victoria St Darlinghurst 2010, NSW
+61 2 92958483
+61 2 92958481
Further information iconv.birzniece@garvan.org.au
Australia

Phase II study investigating the ability of Macrophage Inhibitory Cytokine-1 (MIC-1) and associated plasma markers to predict response to chemotherapy in men with metastatic castrate-resistant prostate cancer

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Trial Information

Trial summary

Advanced prostate cancer is the second leading cause of cancer death in Australian men. Chemotherapy (Docetaxel) is effective in only 50% of patients with this disease. A molecule, MIC-1, is a potential predictive blood marker and mediator of Docetaxel resistance. This clinical trial will test whether the MIC-1 blood test is a predictor of Docetaxel resistance.

Broad Health ConditionMetastatic castrate-resistant prostate cancer

Specific Health ConditionCancer
Prostate

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/01/2010

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1.	Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.
2.	Confirmed castrate-resistant prostate cancer (CRPC) with a minimum of 4 weeks having elapsed between the withdrawal of antiandrogens and enrolment.
3.	Patients must have a baseline serum PSA > 10 ng/ml (referred to as PSA #1), and two consecutive rises in serum PSA (referred to as PSA #2 and PSA #3) greater than PSA #1 with each test performed at least one week apart. If PSA #3 is less than PSA #2, the patient remains eligible provided a fourth PSA (PSA #4) is greater than PSA #2.
4.	Age > 18 years.
5.	Eastern Cooperative Oncology Group Performance status 0-3.
6.	A neutrophil count of at least 1500 per cubic millimetre and a platelet count of at least 100 000 per cubic millimetre.
7.	Normal bilirubin level and aspartate aminotransferase, alanine aminotransferase and serum creatinine no more than 1.5 times the upper limit of the normal range.
8.	Castrate testosterone levels due to either gonadotrophin-releasing hormone (GNRH) agonists or orchidectomy.
9.	Informed consent.

Minimum age18 Years

GenderMales

Can Healthy volunteers participate?No

Key exclusion criteria

1. No histological diagnosis of prostate cancer
Contact details and further information

Sponsor Primary Sponsor Type: Government body
Primary Sponsor Name: Cancer Australia
Primary Sponsor Address: PO Box 1201 Dickson ACT 2602
Primary Sponsor Country: Australia

Trial IDACTRN12611000540910

Contact person for information and recruitment
A./Prof. Lisa Horvath
Sydney Cancer Centre Missenden Rd Camperdown NSW 2050
612 9515 5494
612 9519 1546
Further information iconlisa.horvath@sswahs.nsw.gov.au
Australia

The Fenofibrate And Microvascular Events in Type 1 diabetes Eye: A randomised trial to evaluate the efficacy on retinopathy and safety of fenofibrate in adults with type 1 diabete. A multicentre double-blind placebo-controlled study in Australia and internationally

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Trial Information

Trial summary

Diabetes is the commonest cause of adult onset blindness. Vision loss, which is irreversible, is a most feared complication of diabetes. A blood fat lowering drug called fenofibrate, available in Australia, has been shown to reduce eye damage in people with Type 2 diabetes by 35-40%, and to prevent eye damage in Type 1 diabetic animal models. This study will evaluate the potential benefits of fenofibrate in 450 adults with Type 1 diabetes who are at high risk of eye damage.

Broad Health ConditionEye disease (retinopathy) in type 1 diabetes mellitus
Diabetic nephropathy in type 1 diabetes mellitus

Specific Health ConditionEye
Diseases / disorders of the eye
Metabolic and Endocrine
Diabetes
Renal and Urogenital
Kidney disease

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,QLD,SA,WA,VIC

Hospital
Hunter Diabetes Centre - Merewether

Hospital
Royal Prince Alfred Hospital - Camperdown

Hospital
Royal North Shore Hospital - St Leonards

Hospital
Concord Repatriation Hospital - Concord

Hospital
St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Hospital
Barwon Health - Geelong Hospital campus - Geelong

Hospital
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

Hospital
Baker Heart and Diabetes Institute - Melbourne

Hospital
Princess Alexandra Hospital - Woolloongabba

Hospital
The Royal Adelaide Hospital - Adelaide

Hospital
Fremantle Hospital and Health Service - Fremantle

Hospital
Prince of Wales Hospital - Randwick

Hospital
Royal Melbourne Hospital - City campus - Parkville

Hospital
The Canberra Hospital - Garran

Hospital
Cairns Base Hospital - Cairns

Hospital
Garvan Institute of Medical Research - Darlinghurst

Hospital
Southern Adelaide Diabetes and Endocrine Services - Oaklands Park

Hospital
Mater Adult Hospital - South Brisbane

Hospital
Sunshine Hospital - St Albans

Hospital
South West Retina Liverpool - Liverpool

Postcode
2170 - Liverpool

Postcode
2291 - Merewether

Postcode
2050 - Camperdown

Postcode
2065 - St Leonards

Postcode
2139 - Concord

Postcode
3065 - Fitzroy

Postcode
3220 - Geelong

Postcode
3081 - Heidelberg West

Postcode
3004 - Melbourne

Postcode
4102 - Woolloongabba

Postcode
5000 - Adelaide

Postcode
6160 - Fremantle

Postcode
2031 - Randwick

Postcode
5046 - Oaklands Park

Postcode
3050 - Parkville

Postcode
2605 - Garran

Postcode
4870 - Cairns

Postcode
2170 - Liverpool South

Postcode
2010 - Darlinghurst

Postcode
4101 - South Brisbane

Postcode
3021 - St Albans

Trial location outside Australia

Country
New Zealand

State
Christchurch, Auckland

Country
Hong Kong

State
Shatin, New Territories

Anticipated date of first participant enrolment1/09/2011

Anticipated date of last participant enrolment31/12/2023

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Eligibility criteria for the main study:
1) Men or non-pregnant women (on acceptable contraception) with T1D* according to standard criteria:
*T1D defined as either (1) T1D diagnosed below 40 years of age and insulin therapy commencing within one year of T1D diagnosis, or (2) T1D diagnosed before, at or after 40 years of age along with:
   i) Documented history of ketoacidosis, and/or
   ii) Documented history of very low or undetectable C-peptide (fasting <200 nmol/L or 0.2 pmol/L), and/or
   iii) Documented history of T1D related autoantibody/ies (anti-GAD, anti-A2, anti-ZnT8).

2) Age 18 years or over;
3) eGFR must exceed 30 ml/min/1.73m2;
4) Must have at least one eligible eye with non-proliferative retinopathy (ETDRS score 35-53 inclusive) confirmed by current retinal photography within the last 3 months (irrespective of prior laser therapy). Note: Any eye having undergone prior pan-retinal laser therapy is not eligible, but prior focal, macular or grid laser does not exclude that eye from eligibility.;
5) All types of insulin therapy, with no restriction by level of HbA1c;
6) Willing and able to comply with all study requirements, including treatment, assessment and clinic visit attendances;
7) Able to personally read and understand the Participant Information and Consent Form and provide written, signed and dated informed consent to participate in the study.

Eligibility criteria for the reference group is limited to age and gender matched individuals who do not have T1D.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

1) Definite indication for or contraindications to fibrate treatment (Other lipid drugs [e.g. statins, ezetimibe, fish oils] are allowed.);
2) Need for bilateral intra-ocular treatment or laser photocoagulation therapy within the next 3 months (this exclusion only applies to retinal laser photocoagulation treatment to the posterior pole i.e. laser correction of corneas for short-sightedness is NOT an exclusion criterion);
3) Prior bilateral pan-retinal photocoagulation (PRP) treatment for diabetic retinopathy;
4) Prior bilateral intra-ocular injection(s) within the last 6 months;
5) Bilateral cataract surgery within the last 6 months;
6) Planned bilateral cataract surgery within the next 12 months;
7) History of any other non-diabetic eye disease that is or is likely to affect bilateral vision;
8) History of photosensitive skin rash or myositis; 
9) Abnormal thyroid function (untreated);
10) Liver function tests exceeding 3xULN;
11) Persistent elevated unexplained blood CPK level above normal range;
12) Documented fasting TG levels >6.5 mmol/L;
13) History of pancreatitis, DVT or pulmonary embolism;
14) Use of investigational drugs in the prior 8 weeks;
15) Any unstable condition in last 3 months including active sepsis, diabetic ketoacidosis; 
16) MI, unstable angina, stroke or heart failure within last 6 months;
17) Diagnosed cancer with ongoing treatment or prognosis anticipated at <5 years;
18) Any obstacle to regular follow-up including scheduled clinic attendances;
19) Prior or planned organ transplantation (including islet cells) with subsequent continued immunosuppression therapy.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: NHMRC Clinical Trials Centre, University of Sydney
Primary Sponsor Address: Medical Foundation Building 92-94 Parramatta Road, Camperdown NSW 2050
Primary Sponsor Country: Australia

Trial websitehttps://ctc.usyd.edu.au/our-work/research-divisions/diabetes/current-research/fame-1-eye-trial/

Trial IDACTRN12611000249954

Contact person for information and recruitmentMrs
Liping Li
Medical Foundation Building 92-94 Parramatta Road Camperdown NSW 2050
+61 2 9562 5000

Further information iconfame1eye.study@sydney.edu.au
Australia

The role of vitamin D in the treatment of nerve pain in diabetes

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Trial Information

Trial summary

Vitamin D deficiency is common amongst people with type 2 diabetes. People with type 2 diabetes frequently develop painful neuropathy ("nerve pain" especially in the feet). The study hypothesis is that vitamin D supplementation may improve symptoms of nerve pain. The study is therefore designed to investigate the impact of vitamin D supplementation on nerve pain in people with type 2 diabetes

Broad Health ConditionNeuropathic pain in type 2 diabetes

Specific Health ConditionMetabolic and Endocrine
Diabetes
Neurological
Other neurological disorders

Trial FocusTreatment

Recruitment statusRecruiting


Postcode
2010

Anticipated date of first participant enrolment1/04/2010

Phase of TrialPhase 2 / Phase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Patients with type 2 diabetes and with painful neuropathy with a serum 25-hydroxyvitamin D level of less than 50 nmol/L

Minimum age40 Years

Maximum age80 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Patients with type 1 or secondary diabetes, hypercalcaemia or renal stone
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: St Vincent's Hospital
Primary Sponsor Address: 390 Victoria Street, Darlinghurst NSW 2010
Primary Sponsor Country: Australia

Trial IDACTRN12610000322033

Contact person for information and recruitment
Paul Lee
Department of Endocrinology Garvan Institute of Medical Research 384 Victoria Street Darlinghurst New South Wales 2010
+61 2 9295 8486
+61 2 9295 8481
Further information iconp.lee@garvan.org.au
Australia

Adrenergic control of protein and fat metabolism in healthy adults

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Trial Information

Trial summary

The study objective is to investigate the metabolic effects of beta2-agonist in humans, including whole body energy expenditure, fat oxidation, protein synthesis and turnover

Broad Health ConditionObesity

Specific Health ConditionMetabolic and Endocrine
Normal metabolism and endocrine development and function

Trial FocusPrevention

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/08/2009

Phase of TrialPhase 1

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Healthy adults

Minimum age20 Years

Maximum age40 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

Any active medical conditions necessitating medication
Contact details and further information

Sponsor Primary Sponsor Type: Government body
Primary Sponsor Name: National Health and Medical Research Council
Primary Sponsor Address: National Health and Medical Research Council National Institute of Clinical Studies GPO Box 4530 Melbourne Vic 3001
Primary Sponsor Country: Australia

Trial websiteNone

Trial IDACTRN12610000161022

Contact person for information and recruitment
Paul Lee
Garvan Institute of Medical Research 384 Victoria Street Darlinghurst New South Wales 2010
+61 2 9295 8486
+61 2 9295 8481
Further information iconp.lee@garvan.org.au
Australia

International Sarcoma Kindred Study: Identification of inherited risk in individuals with sarcoma

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Trial Information

Trial summary

This study aims to identify inherited risk in individuals with sarcoma to aid in the creation of a research resource consisting of biospecimens and associated data.
Who is it for?
You may be eligible to join this study if you have been diagnosed with sarcoma. 
Study details
Participants will be identified at key sarcoma clinics, asked to complete a questionnarie and provide biospecimens (blood and tissue). The biospecimens will be stored indefinitely in a tissue bank to be utilised by researchers investigating genetic factors contributing to cancer. Information obtained from the questionnaire will be used to ascertain the family history of cancer and other factors that may contribute to development of the disease. The ongoing nature of the project will enable continual provision of important practical information for clinicians and patients leading to more favourable outcomes.
Sarcomas contribute disproportionately to cancer burden in our community, because they affect the young, treatment is costly and prolonged and morbidity and mortality is high. Genetic factors appear important in sarcomas, although they have not been well studied for the adult population. Early detection by identifying those at risk may lead to better prognoses. This project aims to create a vital research resource to enable further study into the genetic factors contributing to the hereditary risk of developing sarcoma. 

Broad Health Conditionsarcoma
genetic mutations

Specific Health ConditionCancer
Sarcoma (also see 'Bone') - soft tissue
Human Genetics and Inherited Disorders
Other human genetics and inherited disorders

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,SA,WA,VIC

Trial location outside Australia

Country
United Kingdom

State
London

Country
India

State
Mumbai

Country
France

State
Lyon

Country
United States of America

State
Utah

Country
Korea, Republic Of

State
Seoul

Country
New Zealand

State
Canterbury

Anticipated date of first participant enrolment1/07/2009

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

All those diagnosed with sarcoma are eligible for inclusion.  Controls must be age matched within 5 years of the proband, be older than or equal to 18 years of age, not have had a cancer diagnosis and not be a blood relative.

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Controls must be older than or equal to 18 years of age
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australasian Sarcoma Study Group
Primary Sponsor Address: Peter MacCallum Cancer Centre 305 Grattan Street Melbourne Victoria 3000
Primary Sponsor Country: Australia

Trial websitewww.australiansarcomagroup.org/sarcomakindredstudy/

Trial IDACTRN12610000120077

UTNU1111-1113-4959

Contact person for information and recruitmentDr
Mandy Ballinger
The Kinghorn Cancer Centre, Garvan Institute of Medical Research, 370 Victoria Street, Darlinghurst, NSW 2010
+61 2 9355 5806
+61 2 9355 5872
Further information iconm.ballinger@garvan.org.au
Australia

Metabolic effects of oestrogen compounds in men with low testosterone

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Trial Information

Trial summary

We aim to investigate the effects of raloxifene (SERM) in hypogonadal men on the growth hormone system and metabolism.

Broad Health ConditionMetabolic effects in men with low testosterone

Specific Health ConditionMetabolic and Endocrine
Normal metabolism and endocrine development and function

Trial FocusTreatment

Recruitment statusRecruiting

Anticipated date of first participant enrolment6/02/2008

Phase of TrialPhase 4

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Hypogonadism (prostate cancer patients on androgen deprivation therapy for at least 6 months)

Minimum age40 Years

Maximum age80 Years

GenderMales

Can Healthy volunteers participate?No

Key exclusion criteria

Androgen deprivation for less than 6 months, metastasis, cancer in other tissues than prostate, diabetes, kidney and liver disease, deep vein thrombosis
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Department of Endocrinology, St Vincent's Hospital
Primary Sponsor Address: 390 Victoria St Darlinghurst, NSW 2010
Primary Sponsor Country: Australia

Trial IDACTRN12608000537358

Contact person for information and recruitment
Prof Ken Ho, MD, FRACP, Head of Dept of Endocrinology, St Vincent’s Hospital
Pituitary Research Unit Garvan Institute of Medical Research 384 Victoria Street Darlinghurst 2010 NSW
02 9295 8482
02 9295 8481
Further information iconk.ho@garvan.org.au
Australia

Metabolic Effects of SERMs (Selective Oestrogen Receptor Modulators) in healthy men and healthy postmenopausal women

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Trial Information

Trial summary

We aim to investigate and compare the effects of raloxifene and tamoxifen (two most commonly used SERMs) in healthy men and women on the growth hormone system and metabolism.

Broad Health ConditionMetabolic effects in healthy men and healthy postmenopausal women

Specific Health ConditionMetabolic and Endocrine
Normal metabolism and endocrine development and function

Trial FocusEducational / counselling / training

Recruitment statusRecruiting


Postcode
2010

Anticipated date of first participant enrolment27/11/2006

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Healthy postmenopausal women and healthy men the same age

Minimum age50 Years

Maximum age80 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

obesity, diabetes, cancer, kidney or liver diseases, deep vein thrombosis
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Department of Endocrinology, St Vincent's Hospital
Primary Sponsor Address: 390 Victoria St Darlinghurst, NSW 2010
Primary Sponsor Country: Australia

Trial IDACTRN12607000586415

Contact person for information and recruitment
Prof Ken Ho, MD, FRACP, Head of Dept of Endocrinology, St Vincent’s Hospital
Pituitary Research Unit Garvan Institute of Medical Research 384 Victoria Street Darlinghurst 2010 NSW
02 9295 8482
02 9295 8481
Further information iconk.ho@garvan.org.au
Australia

Prospective Study to investigate the ability of the Glutathione S- transferase Pi (GSTP1) methylation assay to assess response to chemotherapy in patients with metastatic hormone-refractory prostate cancer

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Trial Information

Trial summary

The purpose of this study is to find out if a new genetic test (GSTP1 methylation) is a better way of assessing patients’ response to chemotherapy compared to the standard methods (eg PSA blood test). In addition, this study will attempt to find new ways of predicting patient’s response to chemotherapy before they start treatment.

Broad Health ConditionPatients with Metastatic hormone-refractory prostate cancer

Specific Health ConditionCancer
Prostate

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/07/2006

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

1. Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.2. Confirmed Hormone-refractory prostate cancer (HRPC) with a minimum of 4 weeks having elapsed between the withdrawal of antiandrogens and enrolment.3. Patients must have a baseline serum Prostate-specific antigen (PSA)> 10 ng/ml (referred to as PSA #1), and two consecutive rises in serum PSA (referred to as PSA #2 and PSA #3) greater than PSA #1 with each test performed at least one week apart. If PSA #3 is less than PSA #2, the patient remains eligible provided a fourth PSA (PSA #4) is greater than PSA #2.4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-3.5. A neutrophil count of at least 1500 per cubic millimetre and a platelet count of at least 100 000 per cubic millimetre.6. Normal bilirubin level and AST, ALT and serum creatinine no more than 1.5 times the upper limit of the normal range. 7. Castrate testosterone levels due to either luteinizing hormone-releasing hormone (LHRH) agonists or orchidectomy.8. Informed consent.

Minimum age18 Years

GenderMales

Can Healthy volunteers participate?No

Key exclusion criteria

 1. Patients taking alternative therapies (eg Saw Palmetto, dehydroepiandrosterone (DHEA), lycopene, PC-SPES, vitamin D, selenium).2. Patients receiving chemotherapy other than Docetaxel or Mitoxantrone (eg cyclophosphamide).
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Dr Lisa Horvath
Primary Sponsor Address: Sydney Cancer Centre Royal Prince Alfred Hospital Missended Rd CAMPERDOWN NSW 2050
Primary Sponsor Country: Australia

Trial IDACTRN12607000077460

Contact person for information and recruitment
Mr Quoc Nguyen
PRIMe The Garvan Institute of Medical Research 384 Victoria St DARLINGHURST NSW 2010
+61 2 92958349
+61 2 9295 84223
Further information iconq.nguyen@garvan.org.au
Australia

HIV Infection And Metabolic Abnormalities Protocol 1 (HAMA 001)

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Trial Information

Trial summary

A prospective, non-randomised, 48 week study of the effect of PI containing and non-PI containing antiretroviral regimens on the expression of adipocyte specific genes, protein levels and cellular structure in HIV-infected individuals, naive to therapy, who are starting therapy for the first time.

Broad Health ConditionHIV
Metabolic abnormality
Lipodystrophy
Cardiovascular disease

Specific Health ConditionInfection
Acquired immune deficiency syndrome (AIDS / HIV)
Cardiovascular
Other cardiovascular diseases

Trial FocusDiagnosis

Recruitment statusRecruiting

Anticipated date of first participant enrolment3/02/2004

Phase of TrialPhase 4

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Be able to provide written consent to perform in the trial.- HIV antibody positive at time of entry to the study.Specific to HAMA part A only:- Be naive to antiretroviral medication.Specific to HAMA part B only:- Have had a minimum total exposure to antiretroviral medications (to include drugs from more than one drug class) of 48 weeks at time of recruitment.- Have had a minimum of 48 weeks interval since completion of HAMA part A.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

General:- Any history of, or ongoing, mental or physical condition (including suspected or known diagnosis of ischaemic heart disease), which, in the opinion of the investigator, would impede the subjects ability to participate in the trial.-  Prior use of growth hormone or glucocorticoid or anabolic steroid products within the previous six months.-  Prior use of supraphysiological doses of testosterone or oestrogen replacement therapy within the previous year.-  Alcohol or substance abuse which in the opinion of the investigator would affect the patients ability to participate in the trial.-  Prior use of any retinoid-containing compound within the previous six months.- Abnormal coagulation.- Previous allergic reaction or known allergy to local anaesthetic.-  Previous or concomitant use of medications, which, in the opinion of the investigator, would affect the subjects ability to participate in all activities involved in the trial.-  Any grade-three laboratory abnormality recorded from screening bloods, which, in the opinion of the investigator, would impede the subjects ability to safely complete all study requirements.-  Any finding on screening clinical examination, which, in the opinion of the investigator, would impede the subjects ability to participate in the rest of the trial.-  PregnancySpecific to HAMA part A only:- Prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors).  Entry of individuals who have had previous antiretroviral therapy as part of Post Exposure Prophylaxis will be at the discretion of the study investigators.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: The University of New South Wales
Primary Sponsor Country: Australia

Trial IDACTRN12605000662662

Contact person for information and recruitment
Patrick WG Mallon
The National Centre in HIV Epidemiology and Clinical Research Level 2 376 Victoria Street Darlinghurst NSW 2010
+61 2 83823107

Further information iconpmallon@nchecr.unsw.edu.au
Australia

Seronegatives And Metabolic Abnormalities Protocol 2 (SAMA 002)

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Trial Information

Trial summary

A randomised study of the effect of treatment with Combivir (zidovudine [AZT] and lamivudine [3TC]) and Kaletra (lopinavir [LPVr]), alone and in combination, on the development of abnormalities in lipid and glucose metabolism in HIV negative healthy subjects

Broad Health ConditionHIV
Lipid metabolism
Glucose metabolism
Metabolic abnormality
Lipodystrophy
Cardiovascular disease

Specific Health ConditionInfection
Acquired immune deficiency syndrome (AIDS / HIV)
Cardiovascular
Other cardiovascular diseases

Trial FocusDiagnosis

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/11/2004

Phase of TrialPhase 4

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Be able to provide written consent to perform in the trial. - HIV antibody negative and HIV DNA negative at time of entry to the study.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Any history of, or ongoing, mental or physical condition (including suspected or known diagnosis of ischaemic heart disease), which, in the opinion of the investigator, would impede the subjects ability to participate in the trial.- History of type I or type II diabetes mellitus or previous treatment with antidiabetic medication. - Prior use of testosterone, oestrogen, growth hormone or other oral glucocorticoid or anabolic steroid products within the previous six months. - Alcohol or substance abuse which in the opinion of the investigator would affect the subjects ability to participate in the trial. - Prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors either in a previous study, as treatment or as part of post-exposure prophylaxis).- Prior use of any retinoid-containing compound within the previous six months. - Abnormal coagulation. - Previous allergic reaction or known allergy to local anaesthetic. - Previous use of psychotropic medications. - Concomitant use of medications, including those metabolised by CYP3A4 enzyme system (appendix C), which, in the opinion of the investigator, would affect the subjects ability to participate in all activities involved in the trial. - Any grade-three laboratory abnormality recorded from screening bloods. - Any grade-two laboratory abnormality recorded from screening bloods, which, in the opinion of the investigator, would impede the subjects ability to safely complete all study requirements. - Gastrointestinal disorders, which may affect drug absorption. - Any finding on screening clinical examination, which, in the opinion of the investigator, would impede the subjects ability to participate in the rest of the trial.- Pregnancy - Evidence of acute or chronic active hepatitis B virus infection by serology performed at baseline. - Evidence of hepatitis C infection by serology performed at baseline.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: The University of New South Wales
Primary Sponsor Country: Australia

Trial IDACTRN12605000661673

Contact person for information and recruitment
Patrick WG Mallon
The National Centre in HIV Epidemiology and Clinical Research Level 2 376 Victoria Street Darlinghurst NSW 2010
+61 2 83823107

Further information iconpmallon@nchecr.unsw.edu.au
Australia

Treatment of glucocorticoid-induced protein wasting

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Trial Information

Trial summary

The primary purpose is to determine whether growth hormone and androgens alter protein metabolism in a way that will reduce protein loss in long-term glucocorticoid users. If so they may be a potential therapy to reduce the skin thinning and muscle weakness that occurs during longterm glucocorticoid use.

Broad Health ConditionLong-term glucocorticoid users with polymyalgia rheumatica
Inflammatory arthritis

Specific Health ConditionInflammatory and Immune System
Rheumatoid arthritis

Trial FocusTreatment

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/07/2004

Phase of TrialPhase 2 / Phase 3

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Receiving prednisone for > 6 months for polymyalgia rheumatica or inflammatory arthritis.

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Diabetes mellitus, cancer, liver or kidney failure.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: St Vincent's Hospital
Primary Sponsor Country: Australia

Trial IDACTRN12605000642684

Contact person for information and recruitment
Professor Ken Ho
Pituitary Research Unit Garvan Institute of Medical Research 384 Victoria St Darlinghurst NSW 2010
+61 2 92958482
+61 2 92958481
Further information iconk.ho@garvan.org.au
Australia

How androgens exert their anabolic effects. Interaction of testosterone and growth hormone at the hepatic level.

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Trial Information

Trial summary

Observations from previous studies suggest that the full action of GH requires the presence of male hormones like Testosterone (T). We will test the hypothesis that T enhances GH effect acting on the liver. We will compare the body protein production after delivering T exclusively to the liver (capsules) and to peripheral tissues (patch).
The first phase (11 weeks, 6 visits) aims to find the T dose which exposes the liver to normal/physiological T levels.
The second phase (16 weeks, 5 visits) will compare the effect of delivering T to the liver and to peripheral tissues.

Broad Health ConditionMen with hypogonadism
Men with hypopituitarism

Specific Health ConditionMetabolic and Endocrine
Diabetes

Trial FocusTreatment

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/06/2005

Phase of TrialPhase 4

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Hypogonadism or hypopituitarism (baseline T < 2 nmol/L)

GenderMales

Can Healthy volunteers participate?No

Key exclusion criteria

No exclusion criteria
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Department of Endocrinology, St Vincents Hospital Sydney
Primary Sponsor Country: Australia

Trial IDACTRN12605000482662

Contact person for information and recruitment
Dr Ken Ho
Professor of Medicine Head Pituitary Research Unit Garvan Institute Chairman Department of Endocrinology Garvan Institute of Medical Research St Vincent's Hospital 384 Victoria Street Darlinghurst NSW 2010
+61 2 92958203
+61 2 92958411
Further information iconk.ho@garvan.unsw.edu.au
Australia

Protein turnover and energy expenditure in normal subjects, growth hormone deficiency, acromegaly and Cushing's syndrome

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Trial Information

Trial summary

Acromegaly, GH deficiency and Cushing's syndrome all alter body protein. The aim was to compare protein metabolism in these 3 conditions to normal subjects, along with how protein metabolism changes following surgical removal of hormone-secreting tumour.

Broad Health ConditionNormal subjects
GH deficiency
Acromegaly
Cushing's syndrome

Specific Health ConditionMetabolic and Endocrine
Other metabolic and endocrine disorders

Recruitment statusRecruiting

Anticipated date of first participant enrolment1/01/1995

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Subjects with GH deficiency, acromegaly and Cushing's syndrome and normal volunteers.

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Cancer, hepatic and renal failure.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: St Vincent's Hospital
Primary Sponsor Country: Australia

Trial IDACTRN12605000445673

Contact person for information and recruitment
Professor Ken Ho
Pituitary Research Unit Garvan Institute of Medical Research 384 Victoria St Darlinghurst NSW 2010
+61 2 92958482
+61 2 92958481
Further information iconk.ho@garvan.org.au
Australia

Impact of short-term low dose glucocorticoids on protein metabolism

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Trial Information

Trial summary

The aim of this study is to determine if short-term low dose glucocorticoids alters protein metabolism in a way that results in protein loss. This information will help in the development of therapies that reverse or prevent protein loss in patients requiring long-term glucocorticoids.

Broad Health ConditionHealthy volunteers

Specific Health ConditionMetabolic and Endocrine
Normal metabolism and endocrine development and function

Trial FocusTreatment

Recruitment statusRecruiting

Anticipated date of first participant enrolment3/01/2005

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Healthy subjects.

Minimum age50 Years

Maximum age80 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Diabetes mellitus, cancer, liver and kidney failure.
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: St Vincent's Hospital
Primary Sponsor Country: Australia

Trial IDACTRN12605000443695

Contact person for information and recruitment
Professor Ken Ho
Pituitary Research Unit Garvan Institute of Medical Research 384 Victoria St Darlinghurst NSW 2010
+61 2 92958482
+61 2 92958481
Further information iconk.ho@garvan.org.au
Australia

Preventing Cognitive Decline With Metformin

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Trial Information

Trial summary

A randomised control study of metformin in people with mild cognitive impairment and without
diabetes mellitus to determine effects on cognitive decline and neuroimaging over 3 years.

Broad Health Conditioncognitive decline
dementia
cerebrovascular disease
insulin resistance
neurodegeneration
inflammation
diabetes

Specific Health ConditionCognitive Decline

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,

Phase of TrialPhase 3

Eligibility

Key inclusion criteria

Inclusion Criteria:

    -  overweight or obese (body mass index >25.0 kg/m2, waist: women>80 cm, men>94cm;

    -  Mild cognitive impairment (Mild Neurocognitive Disorder), based on DSM-5 criteria;

    -  Fasting blood glucose <7.0 mmol/L and HbA1c <6.5%;

    -  Able to undertake neurocognitive testing in English.

    -  Not participating in another trial of drugs or lifestyle modification to reduce
       cognitive decline.

  Exclusion Criteria:

    -  Life-threatening illnesses to preclude participation in a 3-year study;

    -  Contraindications to the use of metformin (severe heart failure or eGFR <40).

Minimum age60 Years

Maximum age80 Years

GenderAll

Can Healthy volunteers participate?Accepts Healthy Volunteers

Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Garvan Institute of Medical Research

Trial websitehttps://clinicaltrials.gov/show/NCT04511416

Trial IDNCT04511416








Personalised Medicine in Pre-diabetes and Early Type 2 Diabetes

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Trial Information

Trial summary

Prediabetes is a common condition in overweight individuals affecting approximately 35% of
American adults and 30% of Australian adults. Like diabetes, prediabetes is a serious risk
factor for cardiovascular disease, eye, kidney and liver disease, and some types of cancer.

Appropriate blood glucose control is crucial in preventing pre-diabetes complications and
onset of diabetes, yet clinical practice, backed by randomised trials, reports that many
patients treated with standard dietary guidelines or with the first-line treatment of
diabetes patients, metformin, do not improve blood glucose control sufficiently.

The overarching goal of the present project is to improve the efficacy of metformin
mono-therapy in pre-diabetes and early type 2 diabetes.

Broad Health ConditionPre Diabetes
Insulin resistance
Metformin
Gut microbiota
Type 2 Diabetes Mellitus

Specific Health ConditionPre Diabetes
Type 2 Diabetes Mellitus

Trial FocusPrevention

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,

Phase of TrialNot Applicable

Eligibility

Key inclusion criteria

Inclusion criteria:

    -  Individuals with pre-diabetes or newly-diagnosed (in the last 6 months) with type 2
       diabetes, fulfilling the following criteria:

    -  Impaired fasting glucose (IFG, plasma glucose [PG]- 5.6 - 6.9 mmol/L, ±0.2 mmol/L)
       and/or impaired glucose tolerance (IGT, 2-h PG 7.8 - 11.0 mmol/L, ±0.2 mmol/L) with or
       without elevated HbA1c (up to 8.0 %).

    -  Willingness to provide written informed consent and willingness to participate and
       comply with the study.

  Exclusion Criteria:

    -  Females planning a pregnancy during the course of the research or 3 months after
       completion of the research project.

    -  Patients with type 1 diabetes, chronically active inflammatory disease, neoplastic
       disease in the previous 3 years, chronic gastrointestinal disorders, including
       inflammatory bowel disease or celiac.

    -  Liver enzymes ALT and/or AST>3-times normal range limit.

    -  Abnormal renal function as measured by (eGFR<45 mL/min/1.73m^2).

    -  Individuals with a history of a psychological illness or condition that may interfere
       with the individual's ability to understand the requirements of the study.

    -  Normo-glycaemia.

    -  HbA1c>8.0%

    -  Cardiovascular event in the previous 6 months.

    -  Current or recent (within 24 months) treatment with a glucose lowering medication
       (i.e. GLP-1 receptor agonist, SGLT2 inhibitor, thiazolidinedione, sulfonylurea, DPP-4
       inhibitor or insulin).

    -  Current or recent (within 3 months) treatment with metformin.

    -  Treatment with an oral steroid.

    -  Treatment with antibiotics/antifungal in the last 3 month.

    -  Treatment with immunosuppressive medications.

    -  Alcohol or substance abuse.

    -  Participants who had received an investigational new drug within the last 6 months.

    -  Participants involved in another clinical study.

    -  Participants who actively lose weight.

    -  Participants who had a bariatric surgery.

Minimum age20 Years

Maximum age70 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Garvan Institute of Medical Research

Trial websitehttps://clinicaltrials.gov/show/NCT03558867

Trial IDNCT03558867








PRecISion Medicine for Children With Cancer

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Trial Information

Trial summary

This is a multicentre prospective study of the feasibility and clinical value of a diagnostic
service for identifying therapeutic targets and recommending personalised treatment for
children and adolescents with high-risk cancer.

Broad Health Conditionchildren
precision medicine
personalised medicine
high-risk cancer
refractory
recurrent
sequencing
patient derived xenograft
molecular profiling
paediatric

Specific Health ConditionChildhood Cancer
Childhood Solid Tumor
Childhood Brain Tumor
Childhood Leukemia
Refractory Cancer
Relapsed Cancer

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,SA,VIC,WA,

Hospital
John Hunter Children's Hospital

Hospital
Sydney Children's Hospital, Randwick

Hospital
The Children's Hospital at Westmead

Hospital
Queensland Children's Hospital

Hospital
Women's and Children's Hospital

Hospital
Royal Children's Hospital

Hospital
Monash Children's Hospital

Hospital
Perth Children's Hospital

Eligibility

Key inclusion criteria

Inclusion criteria (all must be met)

    1. Age = 21 years

    2. Histologic diagnosis of high-risk malignancy defined as expected overall survival <
       30% OR where standard therapy would result in unacceptable and severe morbidity

    3. Appropriate tissue samples are available for analysis

    4. Life expectancy > 6 weeks

    5. Written informed consent

Maximum age21 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Sydney Children's Hospitals Network

Trial websitehttps://clinicaltrials.gov/show/NCT03336931

Trial IDNCT03336931