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

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

Inclusion Criteria:

* 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 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.

Conditions2

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