RecruitingNCT07453082
A Prospective Study to Evaluate miRNA371 and Outcomes in Patients With Newly Diagnosed Germ Cell Tumors
A Prospective Observational Cohort Study to Evaluate miRNA371 and Outcomes in Patients With Newly Diagnosed Germ Cell Tumor
Sponsor
Fondazione del Piemonte per l'Oncologia
Enrollment
100 participants
Start Date
Jul 1, 2021
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Sex: MALEMin Age: 18 Years
Inclusion Criteria7
- 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 Criteria3
- 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07453082