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Keyword: garvan
Recruitment Status: Recruiting
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
Recruitment statusRecruiting
Anticipated date of first participant enrolment1/04/2010
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
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 8481p.lee@garvan.org.au
Australia
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
Recruitment statusRecruiting
Anticipated date of first participant enrolment1/08/2009
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 8481p.lee@garvan.org.au
Australia
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
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
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 5872m.ballinger@garvan.org.au
Australia
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
Recruitment statusRecruiting
Anticipated date of first participant enrolment6/02/2008
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
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 8481k.ho@garvan.org.au
Australia
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
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
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 8481k.ho@garvan.org.au
Australia
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
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).
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 84223q.nguyen@garvan.org.au
Australia
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
Recruitment statusRecruiting
Anticipated date of first participant enrolment3/02/2004
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.
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 83823107pmallon@nchecr.unsw.edu.au
Australia
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
Recruitment statusRecruiting
Anticipated date of first participant enrolment1/11/2004
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.
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 83823107pmallon@nchecr.unsw.edu.au
Australia
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
Recruitment statusRecruiting
Anticipated date of first participant enrolment1/07/2004
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.
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 92958481k.ho@garvan.org.au
Australia
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
Recruitment statusRecruiting
Anticipated date of first participant enrolment1/06/2005
Key inclusion criteria
Hypogonadism or hypopituitarism (baseline T < 2 nmol/L)
GenderMales
Can Healthy volunteers participate?No
Key exclusion criteria
No exclusion criteria
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 92958411k.ho@garvan.unsw.edu.au
Australia
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
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.
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 92958481k.ho@garvan.org.au
Australia
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
Recruitment statusRecruiting
Anticipated date of first participant enrolment3/01/2005
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.
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 92958481k.ho@garvan.org.au
Australia
Trial summary
CORIA is an observational cohort study of immunosuppressed populations who test positive for COVID-19. This includes people living with HIV, cancer, acquired immunodeficiency associated with other immunosuppressive therapy, primary immunodeficiency and recipients of a solid organ transplant. Participants will have routine clinical data collected with optional baseline collection and storage of a blood sample for storage . The study will be conducted in up to 30 sites within Australia.
Broad Health Condition
Specific Health ConditionHIV-1-infection
Cancer
Primary Immune Deficiency Disorder
Immunosuppression Disorders
COVID-19
Recruitment statusRecruiting
Recruitment Details
Recruitment State
NSW,
Hospital
St Vincent's Hospital
Hospital
Royal North Shore Hospital
Hospital
Blacktown Hospital
Hospital
Liverpool Hospital
Hospital
St George Hospital
Hospital
Concord Hospital
Hospital
Nepean Hospital
Hospital
Westmead Hospital
Key inclusion criteria
Inclusion Criteria: 1. Presenting (in person or via telemedicine) for evaluation because they: - Have clinical symptoms consistent with for COVID-19: - Fever (= 37.8 °C) on examination OR patient reported fever (= 37.8 °C) or feverishness (felt febrile but did not take temperature) OR any of, cough, sore throat, shortness of breath, rhinorrhoea, headache, chills, generalise myalgia, malaise, fatigue, confusion, diarrhea, nausea or vomiting - Have been contacted because they have been identified as a contact to a confirmed case - Have been contacted and told they tested positive for COVID-19 2. Have one of the following conditions affecting immune function: - Known or suspected primary immunodeficiency, defined as a predisposition to infection associated with an apparent or presumed deficit of immune function - On immunosuppressive therapy - Treatment with immune checkpoint inhibitors within 36 months of enrolment date - HIV infection - Diagnosis of cancer within 36 months of enrolment date, excluding superficial basal cell and squamous cell carcinomas - Solid organ transplantation 3. For optional biobanking only, ability to provide informed consent Exclusion Criteria: - Nil
Minimum age18 Years
GenderAll
Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Kirby Institute
Trial websitehttps://clinicaltrials.gov/show/NCT04354818
Trial IDNCT04354818
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
Recruitment statusRecruiting
Recruitment Details
Recruitment State
NSW,
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
Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Garvan Institute of Medical Research
Trial websitehttps://clinicaltrials.gov/show/NCT03558867
Trial IDNCT03558867
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
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
Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Sydney Children's Hospitals Network
Trial websitehttps://clinicaltrials.gov/show/NCT03336931
Trial IDNCT03336931