Actively Recruiting
A Prospective Observational Cohort Study to Evaluate miRNA371 and Outcomes in Patients With Newly Diagnosed Germ Cell Tumor
Led by Fondazione del Piemonte per l'Oncologia · Updated on 2026-03-05
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the plasma expression of miRNA 371a-3p (miRNA 371) as a specific marker to detect the presence or absence of viable germ cell malignancy in male patients newly diagnosed with testicular germ cell tumors or those with a history of this cancer. This observational cohort study aims to understand how well miRNA 371 can indicate relapse risk in early-stage testicular seminoma and nonseminoma groups. The study is sponsored by Fondazione del Piemonte per l'Oncologia and focuses on measuring miRNA levels and relapse outcomes over 48 months. Patients are grouped based on their risk of relapse: low risk (5-25% chance) or moderate risk (26-50% chance). Those in the low-risk group will follow a low-intensity schedule involving biospecimen collection and imaging, while the moderate-risk group will have a higher intensity schedule including additional early imaging and classic cancer marker tests. The study observes these patients without administering any investigational treatments. Participants will undergo regular blood tests to measure miRNA 371 levels and classic tumor markers like beta-HCG, AFP, and LDH. Imaging and clinical evaluations will be done within 42 days before registration and monitored over the 48-month study period. Researchers will track relapse rates, relapse-free survival, and overall survival, collecting pathology reports and performance status data. Participants must provide informed consent and blood samples throughout the study duration.
CONDITIONS
Brief Title
A Prospective Study to Evaluate miRNA371 and Outcomes in Patients With Newly Diagnosed Germ Cell Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years of age or older.
- Patients must have a new diagnosis of germ cell tumor confirmed by pathology or serology.
- All primary sites, stages, and histological subtypes of germ cell tumor are eligible.
- Metachronous second primary germ cell tumors are eligible.
- Male patients with Clinical Stage I testicular cancer must have orchiectomy completed within 42 days prior to registration if surgery is planned.
- Patients must have risk of relapse assessment determined by the local investigator prior to registration.
- Initial imaging, laboratory, and clinical evaluations must be performed within 42 days prior to registration.
- Beta-HCG, AFP, and LDH assessments must be done within 42 days prior to registration.
- Patients must agree to provide informed consent and blood specimens for the duration of the study.
You will not qualify if you...
- Patients with high risk of relapse or metastatic disease.
- Patients with tumor assessments beyond the time frame required by the protocol.
- Patients not compliant with the protocol schedule.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for initial imaging, laboratory, and clinical evaluations
Duration - Up to 48 months
Participants are monitored with biospecimen collection and imaging according to their assigned risk of relapse group to evaluate miRNA371 levels and detect germ cell malignancy.
Visit frequency varies by risk group with low risk participants undergoing low intensity assessments and moderate risk participants undergoing higher intensity assessments including early repeat imaging and marker determination
Trial Site Locations
Total: 1 location
1
Fondazione del Piemonte per l'Oncologia
Candiolo, Turin, Italy, 10060
Actively Recruiting
Research Team
P
Pasquale Rescigno, MD
I
Ilaria Buondonno, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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