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

A Prospective Observational Cohort Study to Evaluate miRNA371 and Outcomes in Patients With Newly Diagnosed Germ Cell Tumor

This project will test whether a blood test measuring miRNA371 can detect active or returning germ cell tumors in men with a new or prior diagnosis of testicular germ cell cancer.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Fondazione del Piemonte per l'Oncologia (Academic / other)
• Locations: 1 site (Candiolo, Turin)
• Trial ID: NCT07453082 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Men aged 18 or older with a new pathologic or serologic diagnosis of a germ cell tumor (or a prior germ cell tumor) who have baseline imaging and tumor marker testing and a documented risk-of-relapse assessment are eligible.

Not a fit: Patients whose tumors do not release miRNA371 (for example, some pure mature teratomas) or who cannot complete the required blood draws and imaging visits are unlikely to gain benefit from this protocol.

Why it matters

Potential benefit: If successful, miRNA371 could allow earlier and more accurate blood-based detection of residual or recurrent germ cell malignancy, potentially reducing unnecessary imaging or delayed diagnosis.

How similar studies have performed: Previous observational studies of miR-371a-3p have shown promising sensitivity and specificity for detecting viable germ cell tumors, but the marker is not yet established as standard clinical practice.

Eligibility criteria

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 this trial is running

Candiolo, Turin

• 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

Conditions Testicular Germ Cell Tumor