miRNA371 blood testing for men with newly diagnosed or prior germ cell tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational cohort enrolling adult men with newly diagnosed or prior germ cell tumors to measure plasma miRNA371 (miR-371a-3p) alongside standard clinical tests. Patients are stratified by estimated relapse risk (low vs. moderate) and followed with predefined schedules of blood collection and imaging, with moderate-risk patients undergoing more intensive sampling and earlier repeat imaging. The study compares miRNA371 levels to classic serum tumor markers (beta-HCG, AFP, LDH) and clinical outcomes to determine whether changes in the microRNA signal correspond with clinically detectable viable germ cell malignancy or relapse. Data collected include pathology, imaging reports, performance status, and serial biospecimens to correlate biomarker dynamics with disease status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must be ≥ 18 years of age.
* Patients must have a new diagnosis of a germ cell tumor confirmed pathologically or serologically (diagnostic elevation of HCG/AFP). All primary sites, stages, histological subtypes of germ cell tumor are eligible. Metachronous second primary germ cell tumors are eligible.
* If surgery is planned, male patients with Clinical Stage I testicular cancer must have orchiectomy completed within 42 days prior to registration.
* Patients must have risk of relapse assessment determined by the local investigator prior to registration.
* Patients must have initial imaging, laboratory and other clinical evaluations (see below) performed within 42 days prior to registration. Imaging reports, pathology reports and performance status will be collected.
* Patients must have beta-human chorionic gonadotropin (beta-HCG), alpha- fetoprotein (AFP), and lactate dehydrogenase (LDH) assessments within 42 days prior to registration.
* Patients must agree to provide informed consent and required blood specimens for the duration of the study.

Exclusion Criteria:

* Patients with high risk of relapse or metastatic disease.
* Patients with tumour assessments beyond the time frame required by the protocol.
* Patients not complaint with the protocol schedule.

Where it's running

• Fondazione del Piemonte per l'Oncologia
  Candiolo, Turin, Italy Recruiting

Study contacts

• Principal investigator: Pasquale Rescigno, MD — Fondazione del Piemonte per l'Oncologia
• Study coordinator: Pasquale Rescigno, MD
• Email: pasquale.rescigno@ircc.it
• Phone: +390119933601

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.