Status:

RECRUITING

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

Lead Sponsor:

Fondazione del Piemonte per l'Oncologia

Conditions:

Testicular Germ Cell Tumor

Eligibility:

MALE

18+ years

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.

Detailed Description

This is a observational cohort study to evaluate miRNA 371 in male patients with history of germ cell tumor or newly diagnosed germ cell tumor. Patients with newly diagnosed testicular germ cell canc...

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.

Key Trial Info

Start Date :

July 1 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT07453082

Start Date

July 1 2021

End Date

December 31 2026

Last Update

March 5 2026

Active Locations (1)

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Fondazione del Piemonte per l'Oncologia

Candiolo, Turin, Italy, 10060