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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Testicular Germ Cell Tumor

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 and imaging requirements.
2. 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.

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Ilaria Buondonno, PhD; Phone Number: +390119933393; Email: ilaria.buondonno@ircc.it
• Study Contact Backup: Name: Pasquale Rescigno, MD; Phone Number: +390119933601; Email: pasquale.rescigno@ircc.it

Study Locations

• Italy
  • Turin
    • Candiolo, Turin, Italy, 10060
      • Recruiting
      • Fondazione Del Piemonte Per L'Oncologia
      • Contact: Ilaria Buondonno, PhD; Phone Number: +390119933393; Email: ilaria.buondonno@ircc.it
      • Contact: Pasquale Rescigno, MD; Phone Number: +390119933601; Email: pasquale.rescigno@ircc.it
      • Principal Investigator: Paquale Rescigno, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed testicular germ cell cancers with:

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 and imaging requirements.
2. 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time 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 Measure	Measure Description	Time 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

Collaborators and Investigators

• Sponsor: Fondazione del Piemonte per l'Oncologia
• Investigators: Principal Investigator: Pasquale Rescigno, MD, Fondazione Del Piemonte Per L'Oncologia

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Testicular Germ Cell Tumor
• Other Study ID Numbers: 023-FPO21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No