An observational study in Testicular Germ Cell Tumor, sponsored by Fondazione del Piemonte per l'Oncologia. Recruiting at 1 site in Italy. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Fondazione del Piemonte per l'Oncologia · Observational
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.
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 cancers will be stratified in:
The BRIDGE study evaluate the plasma expression of miRNA 371 as biomarker of relapse and its ability to detect germ cell malignancy within each of the early stage testicular seminoma and nonseminoma groups.
Fondazione del Piemonte per l'Oncologia is the lead sponsor of 39 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with newly diagnosed testicular germ cell cancers with:
Exclusion Criteria:
Low risk of relapse (5-25% chance of recurrence with active germ cell malignancy): patients with low risk designation will be assigned to a low intensity schedule of biospecimen collection and imaging requirements.
Moderate risk of relapse (26-50% chance of recurrence): patients with moderate risk designation will be assigned to a higher intensity schedule of biospecimen collection and imaging requirements including early repeat imaging and classic marker determination.
Misure of the level of miRNA37 in plasma samples
The study will prospectively collect samples and performed scans to evaluate the ability of miRNA371 in detecting (or anticipate) disease progression.
Time frame: 48 months
Presence/absence of malignant cells detected by miRNA371
The study will validate the capacity of miRNA371 to assess the presence of viable malignant cells otherwise not visible with standard imaging.
Time frame: 48 months
Relapse on Surveillance
Evidence of unequivocal clinically or pathologically confirmed recurrent germ cell tumor on surveillance
Time frame: 48 months
Relapse on Treatment
Evidence of unequivocal clinically or pathologically confirmed germ cell tumor during or after specific treatment for germ cell tumor including chemotherapy, radiation therapy or surgery
Time frame: 48 months
Relapse Free Survival
Relapse free survival is measured from the date of orchiectomy until the date of first observation of relapse on surveillance, or from the date of achieving complete remission until the date of first observation of relapse on treatment, or death due to any cause. Patients last known to be alive and without report of relapse are censored at date of last contact
Time frame: 48 months
Overall Survival
Overall survival is measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact
Time frame: 48 months
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Testicular Germ Cell Tumor
Fondazione del Piemonte per l'Oncologia