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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorFondazione del Piemonte per l'Oncologia

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

100 Participants
are grouped into 2 trial groups