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

Recruitingn/aAges 18 Years - anyMaleFondazione del Piemonte per l'Oncologia
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients must be โ‰ฅ 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.
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What it tests

  • Not listed
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Where

1 site
Fondazione del Piemonte per l'Oncologia
Candiolo, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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