Observational Study to Evaluate miRNA371 as a Marker and Outcomes in Men with Newly Diagnosed Germ Cell Tumors

What this Trial Is About

Researchers are evaluating the plasma expression of miRNA 371a-3p miRNA 371 as a specific marker to detect the presence or absence of viable germ cell malignancy in male patients newly diagnosed with testicular germ cell tumors or those with a history of this cancer. This observational cohort study aims to understand how well miRNA 371 can indicate relapse risk in early-stage testicular seminoma and nonseminoma groups. The study is sponsored by Fondazione del Piemonte per lOncologia and focuses on measuring miRNA levels and relapse outcomes over 48 months. Patients are grouped based on their risk of relapse low risk 5-25% chance or moderate risk 26-50% chance. Those in the low-risk group will follow a low-intensity schedule involving biospecimen collection and imaging, while the moderate-risk group will have a higher intensity schedule including additional early imaging and classic cancer marker tests. The study observes these patients without administering any investigational treatments. Participants will undergo regular blood tests to measure miRNA 371 levels and classic tumor markers like beta-HCG, AFP, and LDH. Imaging and clinical evaluations will be done within 42 days before registration and monitored over the 48-month study period. Researchers will track relapse rates, relapse-free survival, and overall survival, collecting pathology reports and performance status data. Participants must provide informed consent and blood samples throughout the study duration.

A Prospective Study to Evaluate miRNA371 and Outcomes in Patients With Newly Diagnosed Germ Cell Tumors