Actively Recruiting

Age: 18Years +
MALE
NCT07453082

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

Led by Fondazione del Piemonte per l'Oncologia · Updated on 2026-03-05

100

Participants Needed

1

Research Sites

287 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 18 years or older
  • New diagnosis of germ cell tumor confirmed by pathology or elevated HCG/AFP
  • All primary sites, stages, and histological subtypes of germ cell tumor are eligible
  • Metachronous second primary germ cell tumors are eligible
  • If surgery is planned for Clinical Stage I testicular cancer, orchiectomy must be completed within 42 days prior to registration
  • Risk of relapse assessment must be done before registration
  • Initial imaging, laboratory, and clinical evaluations must be completed within 42 days prior to registration
  • Beta-HCG, AFP, and LDH blood tests must be done within 42 days prior to registration
  • Patients must agree to provide informed consent and blood samples for the study duration
Not Eligible

You will not qualify if you...

  • High risk of relapse or metastatic disease
  • Tumor assessments performed outside the required protocol time frame
  • Non-compliance with the study protocol schedule

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fondazione del Piemonte per l'Oncologia

Candiolo, Turin, Italy, 10060

Actively Recruiting

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Research Team

P

Pasquale Rescigno, MD

CONTACT

I

Ilaria Buondonno, PhD

CONTACT

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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