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
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Misure of the level of miRNA37 in plasma samples — 48 months The study will prospectively collect samples and performed scans to evaluate the ability of miRNA371 in detecting (or anticipate) disease progression.
Presence/absence of malignant cells detected by miRNA371 — 48 months The study will validate the capacity of miRNA371 to assess the presence of viable malignant cells otherwise not visible with standard imaging.
Trial sites (1)
Facility
City
Region
Status
Fondazione del Piemonte per l'Oncologia
Candiolo
Turin
Recruiting
More Fondazione del Piemonte per l'Oncologia trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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