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Clinical Trial NCT07453082 (BRIDGE) for Testicular Germ Cell Tumor is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Prospective Study to Evaluate miRNA371 and Outcomes in Patients With Newly Diagnosed Germ Cell Tumors (BRIDGE) 100 Observational

Recruiting
Clinical Trial NCT07453082 (BRIDGE) is an observational study for Testicular Germ Cell Tumor that is recruiting. It started on 1 July 2021 with plans to enroll 100 participants. Led by Fondazione del Piemonte per l'Oncologia, it is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 5 March 2026.
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 cancers will be stratified in:

  1. 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 ...
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Official Title

A Prospective Observational Cohort Study to Evaluate miRNA371 and Outcomes in Patients With Newly Diagnosed Germ Cell Tumor

Conditions
Testicular Germ Cell Tumor
Other Study IDs
  • BRIDGE
  • 023-FPO21
NCT ID Number
NCT07453082
Start Date (Actual)
2021-07-01
Last Update Posted
2026-03-05
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
100
Study Type
Observational
Status
Recruiting
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Low risk of relapse
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.
N/A
Moderate risk of relapse
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.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
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.
48 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Relapse on Surveillance
Evidence of unequivocal clinically or pathologically confirmed recurrent germ cell tumor on surveillance
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
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
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
48 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
  • 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.

  • 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.
Fondazione del Piemonte per l'Oncologia logoFondazione del Piemonte per l'Oncologia
Study Central Contact
Contact: Pasquale Rescigno, MD, +390119933601, [email protected]
Contact: Ilaria Buondonno, PhD, +390119933393, [email protected]
1 Study Locations in 1 Countries

Turin

Fondazione del Piemonte per l'Oncologia, Candiolo, Turin, 10060, Italy
Pasquale Rescigno, MD, Contact, +390119933601, [email protected]
Ilaria Buondonno, PhD, Contact, +390119933393, [email protected]
Paquale Rescigno, MD, Principal Investigator
Recruiting