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.

Not Applicable

Recruiting

• Conditions: Germ Cell Tumour (GCT); Seminoma; Testicular cancer; Cancer - Testicular

• Registration Number: ACTRN12618000931279
• Lead Sponsor: Walter and Eliza Hall Institute for Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-01
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 800

Inclusion Criteria

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 Criteria

No archival tissue specimen available.
Patient not accessible for follow up and data collection.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with stage 1 seminoma and non-seminoma that relapse as assessed from each patient's medical record.[Primary timepoint is the end of 10 year data collection and molecular analyses of archival tumour specimens and blood collections,]