A Study of miRNA 371 in Patients With Germ Cell Tumours

Official Title

A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients With Newly Diagnosed Germ Cell Tumours

Summary:

This trial studies whether the blood marker micro ribonucleic acid (miRNA) 371 can predict the chance of cancer returning in patients with germ cell cancers. Studying samples of blood from patients with germ cell cancers in the laboratory may help doctors predict how likely the cancer will come back.

Trial Description

Primary Outcome:

• To estimate positive predictive value of miRNA 371 in early stage testicular seminoma and nonseminoma patients
• To bank blood specimens of patients at low risk and moderate risk of relapse

Primary Objectives:

• To estimate the positive predictive value within each of the early stage testicular seminoma and nonseminoma groups using plasma miRNA 371 expression at relapse to detect germ cell malignancy.

Secondary Objectives:

• To bank prospectively obtained serial liquid biospecimens for low and moderate risk of relapse patients annotated by patient level clinical data.
• To bank prospectively collected, clinically annotated specimens for high risk patients and non-testicular primary patients in collaboration with Children's Oncology Group study AGCT 1531.

Patients undergo collection of blood every 3-6 months for up to 3 years.

View this trial on ClinicalTrials.gov