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

NCT07453082 | Recruiting

• 1 other identifier: 023-FPO21
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Testicular Germ Cell Tumor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Relapse on Surveillance

  48 months

• Relapse on Treatment

  48 months

• Relapse Free Survival

  48 months

• Overall Survival

  48 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (1)

Fondazione del Piemonte per l'Oncologia

Candiolo, Turin, 10060, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

10 ml of blood will be collected at the time points listed below in Streck cell-free DNA collection tube. Schedule is based on the patient's risk of relapse category. Specimens for miRNA 371 analysis will be collected at the time of standard of care clinical blood draws in order to minimize blood draws in the subject. Submission Schedule for Low Risk of Relapse Patients: * Baseline * Month 6 * Month 12 * Month 18 * Month 24 * Month 36 * At relapse Submission Schedule for Moderate-Risk Patients: * Baseline * Month 3 * Month 6 * Month 9 * Month 12 * Month 15 * Month 18 * Month 21 * Month 24 * Month 30 * Month 36 * At relapse

MeSH Terms

Conditions

Testicular Germ Cell Tumor

Study Officials

• Pasquale Rescigno, MD

  Fondazione del Piemonte per l'Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pasquale Rescigno, MD

CONTACT

+390119933601; pasquale.rescigno@ircc.it

Ilaria Buondonno, PhD

CONTACT

+390119933393; ilaria.buondonno@ircc.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: March 5, 2026
• Study Start: July 1, 2021
• Primary Completion: July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

IT (1)