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
Walter and Eliza Hall Institute for Medical Research
800 participants
Feb 1, 2016
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
Inclusion Criteria5
- Histologically or cytologically confirmed GCT (non-seminoma or seminoma); or exceptionally raised tumour markers (AFP greater than or equal to 1000ng/mL and/or HCG greater than or equal to 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently.
- Primary arising in testis, retro-peritoneum, or mediastinum.
- Able to be accessible for follow-up and data collection.
- Written, voluntary and informed consent.
- Able to undergo collection of blood specimens.
Exclusion Criteria2
- No archival tissue specimen available.
- Patient not accessible for follow up and data collection.
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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 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)
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ACTRN12618000931279