NCT07453082 A Prospective Study to Evaluate miRNA371 and Outcomes in Patients With Newly Diagnosed Germ Cell Tumors
| NCT ID | NCT07453082 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione del Piemonte per l'Oncologia |
| Condition | Testicular Germ Cell Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-07-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-07-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a observational study aimed at evaluating miRNA 371a-3p (miRNA 371) as a specific marker for presence or absence of clinically detectable viable germ cell malignancy.
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.
Contact & Investigator
Pasquale Rescigno, MD
PRINCIPAL INVESTIGATOR
Fondazione del Piemonte per l'Oncologia
Frequently Asked Questions
Who can join the NCT07453082 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Testicular Germ Cell Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07453082 currently recruiting?
Yes, NCT07453082 is actively recruiting participants. Contact the research team at pasquale.rescigno@ircc.it for enrollment information.
Where is the NCT07453082 trial being conducted?
This trial is being conducted at Candiolo, Italy.
Who is sponsoring the NCT07453082 clinical trial?
NCT07453082 is sponsored by Fondazione del Piemonte per l'Oncologia. The principal investigator is Pasquale Rescigno, MD at Fondazione del Piemonte per l'Oncologia. The trial plans to enroll 100 participants.