RecruitingACTRN12618000931279

Identifying and validating predictive and prognostic biomarkers in male Germ Cell Tumours to improve the management and outcomes in both stage 1 and disseminated disease.

Assessing Predictive and Prognostic Biomarkers in Germ Cell Tumours - Testis


Sponsor

Walter and Eliza Hall Institute for Medical Research

Enrollment

800 participants

Start Date

Feb 1, 2016

Study Type

Observational

Conditions

Summary

The purpose of this study is to investigate the patterns of relapse for germ cell tumours of the testicle. Who is it for? You may be eligible for this study if you are a male over 18 and have a confirmed germ cell tumour (both seminomas and non-seminomas). Study details In this study, participants will be asked to complete treatment for their cancer as per normal while being monitored by researchers every 6 months while you are on active surveillance. This will involve taking some blood and tissue samples as well as answering a few questionnaires. Researchers will then look at the differences in the tissue and blood to see how these differences relate to how the participant responded to treatment. It is hoped that this research will help us understand why some germ cell tumours are more aggressive than others and why some treatments work better in some patients than others.


Eligibility

Sex: MalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Testicular cancer (germ cell tumour) is the most common cancer in young men, and while most cases are curable, doctors don't yet fully understand why some tumours come back after treatment and others don't. This study, run by the Walter and Eliza Hall Institute, aims to build a biobank and data registry to track patients over time and identify markers in the blood and tumour tissue that might predict who is at higher risk of relapse. Participants will continue with their standard cancer treatment while providing blood and tissue samples every six months during active surveillance. Questionnaires will also be completed periodically. This information will help researchers understand the biology of these tumours at a deeper level. You may be eligible if you are male, 18 or older, and have been confirmed to have a germ cell tumour (either a seminoma or non-seminoma type). You must be able to attend follow-up appointments and be willing to provide blood and tissue samples. Men who do not have archival tissue available or who cannot be followed up are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Enrolled patients diagnosed with germ cell tumours will donate a sample of tissue taken during their previous and or future surgery and or biopsy and information will be collected regarding their gene

Enrolled patients diagnosed with germ cell tumours will donate a sample of tissue taken during their previous and or future surgery and or biopsy and information will be collected regarding their general health, the type of cancer treatments they have had, how their cancer responded to the treatment, any side effects from the treatment, and other personal details such as age. Additionally, they will be asked to donate blood samples, up to 50ml (2 to 3 tablespoons), for research purposes on the following occasions: • Before and after surgical removal of their germ cell tumour (if applicable) • Before and after any chemotherapy regimen (if applicable) • Every 6 months while on active surveillance (if applicable) We will try to ensure that the collection of bloods for research will be done at the same time as blood collections for tests that patients would otherwise have as part of routine care. Overall duration of follow-up for each study participant is 10 years or loss to follow-up.


Locations(6)

Royal Melbourne Hospital - City campus - Parkville

VIC, Australia

Peter MacCallum Cancer Centre - Melbourne

VIC, Australia

Western Hospital - Footscray - Footscray

VIC, Australia

Epworth Freemasons - Melbourne

VIC, Australia

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

VIC, Australia

Austin Health - Austin Hospital - Heidelberg

VIC, Australia

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