Trial summary

Obesity is a major health issue worldwide. Despite global research efforts, effective treatments for obesity are limited. There are two kinds of fat in the body: white fat and brown fat. White fat functions mainly as an energy-storing organ and in excess results in obesity and complications such as diabetes and high blood pressure. Brown fat on the other hand releases the energy stored in fat as heat. It protects small animals and newborn human infants from cold temperatures. 

New imaging techniques have revealed brown fat to be present in significant amount in adult humans. Using special metabolic imaging, called PET scanning, brown fat is shown to be more abundant in lean individuals with lower blood glucose levels, suggesting that brown fat may regulate energy balance and metabolism. 

In animals, cold temperature and food both stimulate brown fat, resulting in release of energy. This is called adaptive thermogenesis, and it represents a considerable portion of total daily energy expenditure. Whether brown fat controls adaptive thermogenesis in humans is unclear. This is clinically relevant because if brown fat regulates adaptive thermogenesis in humans, strategies can be developed to stimulate brown fat to increase energy expenditure, which may be a new method to help attain weight control and develop treatment of obesity-related disorders.

In order to determine the physiologic significance of brown fat activation, we designed a study investigating the effects of cold exposure and food on brown fat in humans. 

We hypothesize that adaptive thermogenesis in adult humans can be activated by cold or food, and the extent depends on individual brown fat abundance. Brown fat activity can be increased by cold stimulation, which could result in beneficial metabolic changes in the body.

The aims of the current project are to:
1)	determine relationship between brown fat and adaptive thermogenesis 
2)	investigate the underlying hormonal mechanisms and significance of brown fat activation 

Brown fat abundance will first be measured by PET scanning during mild cold condition. Volunteers then undergo metabolic and hormonal testing at standard ambient temperature (24 degrees). A parallel study will examine brown fat biopsies obtained during elective neck surgery to investigate mechanisms underlying brown fat activation. 

Significance: Based on its role in energy homeostasis and protection against obesity in animals, brown fat is likely to have a similar role in adult humans. Determining the contribution of brown fat to energy metabolism may lead to novel treatment strategies of obesity.

Broad Health ConditionObesity
Diabetes

Specific Health ConditionMetabolic and Endocrine
Metabolic disorders
Diet and Nutrition
Obesity
Metabolic and Endocrine
Diabetes

Trial FocusDiagnosis

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Anticipated date of first participant enrolment1/04/2014

Anticipated date of last participant enrolment31/07/2015

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

Healthy volunteers

Minimum age18 Years

Maximum age40 Years

GenderBoth males and females

Can Healthy volunteers participate?Yes

Key exclusion criteria

Body mass index > 30 kg/m2.
Significant cardiac, respiratory, thyroid, renal and/or hepatic dysfunction

Trial summary

This project is a pilot study that aims to evaluate the accuracy of digital X­ray radiogrammetry (DXR) in determining bone mineral density (BMD), as compared to BMD by dual energy X­ray absorptiometry (DXA). Participants will be women aged fifty years or older who are postmenopausal and are attending for a follow up mammogram.

DXR is a method that can be used to estimate BMD from plain digital hand X­ray images. It assesses BMD from images of the mid 2nd, 3rd and 4th metacarpals. The data is then transmitted in deidentified fashion to Sectra, a Swedish company that has developed the ‘OneScreen’ technology, that combines both mammography and digital X­ ray radiogrammetry. A BMD in g/cm2, a T­score and a Z­score are then transmitted back within minutes. A number of studies have demonstrated that T and Z­scores derived from such DXR examinations correlate closely to values derived by DXA, which is considered the gold standard for screening or follow up bone densitometry. BMD by DXR has been shown to predict fracture risk, similarly to DXA.

Women over the age of 50 who are postmenopausal may already have low BMD and are at risk of further BMD reductions. Women who attend for follow up mammography are, in addition, a group who may require breast surgery and possibly aromatase inhibitors that eliminate sex steroid production and increase fracture risk. The addition of a digital hand X­ray for DXR analysis to the mammography examination requires no additional equipment and takes only a few seconds. If DXR is shown to correlate closely to DXA in our local population, it has potential to be used in osteoporosis screening for women who may require aromatase inhibitors. If cost effective, it might even be considered as a screening tool when women attend for routine mammography, because women screened for breast cancer are the same group who may benefit from awareness of low BMD.

After ethical approval of this study and after participants have provided informed consent, data will be collected from women over the age of 50 who are post­menopausal and who present for a second mammogram after having a positive screening mammogram in the community. The women will complete a short questionnaire following which DXR of the hand will be performed immediately after mammography and the DXR images will be transmitted for analysis. This de­identified data is generally returned within 5 minutes with BMD Z and T­scores. 

Participants will also undergo a DXA examination of the forearm, hip and spine to allow a comparison of the DXR measurements. Participants with results by DXA that indicate a BMD in the osteopaenic range will be provided with a letter which can be taken to their general practitioner for further discussion. Any participant with a BMD in the osteoporotic range will be given a letter for their general practitioner who will also be informed of the result by telephone. For participants with T­scores less than ­3 (indicating osteoporotic­range BMD at or greater than 3 standard deviations below the mean), referral to a specialist will also be suggested. While physicians associated with this study will be available to discuss any result with a participant, they will not be involved in ongoing management for ethical reasons.

To date, DXR using the Sectra system has not been used in Australia, but has undergone evaluation at single sites in the UK, Sweden and the USA. If the technique proves accurate for BMD evaluation in this pilot study, wider application for BMD evaluation in women undergoing mammography might be considered. Compared to DXA, it would be more simple and convenient, is lower radiation and may be cost effective enough to consider as a screening tool in either specific circumstances (such as follow up mammography) or for general postmenopausal evaluation.

Broad Health ConditionOsteoporosis

Specific Health ConditionMusculoskeletal
Osteoporosis

Trial FocusDiagnosis

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
Westmead Hospital - Westmead

Postcode
2145 - Westmead

Anticipated date of first participant enrolment6/08/2014

Anticipated date of last participant enrolment31/10/2015

Phase of TrialPhase 4

Has the study received ethics approval?Approved

Key inclusion criteria

All participants included will be women who are postmenopausal and over the age of 50

Minimum age50 Years

GenderFemales

Can Healthy volunteers participate?Yes

Key exclusion criteria

Male, premenopausal, less than 50 years old, physically unable to meet the criteria required for the study

Trial summary

The primary aim of the study is to investigate the impact of telmisartan treatment on brown fat in humans. The hypothesis is that telmisartan recruits brown fat in humans, thereby improving glucose metabolism.

Broad Health ConditionHypertension
Overweight

Specific Health ConditionMetabolic and Endocrine
Metabolic disorders
Cardiovascular
Hypertension
Diet and Nutrition
Obesity

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Postcode
2010 - Darlinghurst

Anticipated date of first participant enrolment16/06/2014

Anticipated date of last participant enrolment1/06/2015

Phase of TrialPhase 2

Has the study received ethics approval?Approved

Key inclusion criteria

1. BMI: 20-30 kg/m2
2. Disease status: uncomplicated hypertension on mono-therapy (ACE inhibitor or calcium channel blockers (CCB)) with stable blood pressure control for > 6 months.
3. Willingness to give written informed consent and willingness to participate to and comply with the study

Minimum age18 Years

Maximum age45 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

* BMI <20 or >30 Kg/m2. 
* Age <18 or >45 years old. 
* Pregnant or breast-feeding.
* History/laboratory (screening test) evidence of significant cardiovascular, endocrine, neoplastic, renal, hepatic or metabolic disorders, including hyperkalaeamia.  
* On more than 1 anti-hypertensive medication.
* Known hypersensitivity to any angiotensin receptor blocker.
* Current diabetes medication therapy (however, patients with pre-diabetes or diet-controlled diabetes not on medication may participate) 
* On therapies with possible effects on brown fat and or glycemia (e.g. beta-agonists (including inhaled formulations), beta-blockers, alpha-blockers, diuretics, glucocorticoids and/or hormone replacement).
* Unwillingness to undergo blood pressure monitoring during treatment phase.
* Claustrophobia.
* History of illicit drug or alcohol abuse within the last 5 years; current use of drugs (by history) or alcohol (CAGE score>3).
* Inability to provide written informed consent
* Current use of medications/dietary supplements/alternative therapies known to alter endocrine/metabolic function.
* Current use of antiplatelet or anticoagulants (if subjects decide to participate in optional tissue biopsies).
* Current smoker or user of tobacco products
* Current participation in weight loss programs (dietary, exercise or pharmacological) or more than 3 kg weight changes in last 6 months 

Trial summary

Osteoporosis is common in the Australian population and is a disease in which the bones lose minerals such as calcium, more quickly than the body can replace them. As a results, the bones become fragile and brittle, leading to higher risk of fractures and a loss of bone mass. 
Bisphosphonates are the main drugs used in the treatment of osteoporosis and work by inhibiting bone loss. Bisphosphonates also have additional effects that are not related to preventing bone loss. These additional effects are thought to be due to their action on the immune system (the cells that fight against disease in the body).
There is no study to date showing that bisphosphonates are taken up by human immune cells and this study will enable us to examine the impact these medications have on the human immune system.

Broad Health ConditionOsteoporosis
Immune system

Specific Health ConditionMusculoskeletal
Osteoporosis
Inflammatory and Immune System
Other inflammatory or immune system disorders

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Postcode
2010 - Darlinghurst

Anticipated date of first participant enrolment12/03/2014

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Key inclusion criteria

Sex: male or female
Age range: 20 years of age or older
Disease status: diagnosis of osteoporosis based on either a T-score of less than or equal to -2.5 SD on bone densitometry or minimal trauma fracture.
Must meet the PBS authority criteria for bisphosphonate therapy.
Concomitant disease status: immunocompetent
Laboratory parameters: eGFR equal to or more than 30
Willingness to give written or informed consent and willingness to participate to and comply with the study.

Minimum age20 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
Laboratory parameters: eGFR < 30
Patients who have received previous anti-resorptive therapy. 
Patients with dental issues requiring extraction or intervention involving the jaw bone.
Patients unable to give informed consent.
Patients receiving medication that may interact with either prenylation or the immune system: statin therapy and immunosuppressant therapy including glucocorticoids

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?Approved

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

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?Approved

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.

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?Approved

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

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
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 enrolment31/12/2022

Phase of TrialPhase 3

Has the study received ethics approval?Approved

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.

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

Anticipated date of first participant enrolment1/04/2010

Phase of TrialPhase 2 / Phase 3

Has the study received ethics approval?Approved

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

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?Approved

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

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?Approved

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

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?Approved

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

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

Anticipated date of first participant enrolment27/11/2006

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

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

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?Approved

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).

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?Approved

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.

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?Approved

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.

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?Approved

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.

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?Approved

Key inclusion criteria

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

GenderMales

Can Healthy volunteers participate?No

Key exclusion criteria

No exclusion criteria

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?Approved

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.

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?Approved

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.