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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

A Study of miRNA 371 in Patients with Germ Cell Tumors

This trial studies whether the blood marker micro ribonucleic acid (miRNA) 371 can predict the chance of cancer returning in patients with germ cell cancers. Studying samples of blood from patients with germ cell cancers in the laboratory may help doctors predict how likely the cancer will come back.
Urologic
N/A
Adults
Not Available
Not Available
Davis, Nancy
International
Vanderbilt University
10-09-2020
Basic Science
ECOGUROS1823
NCT04435756

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

Patients must have a new diagnosis of a germ cell tumor. confirmed pathologically or serologically (diagnostic elevation of human chorionic gonadotropin [HCG]/alpha-fetoprotein [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 be registered within 42 days after diagnosis and prior to initiation of a management plan or treatment for the disease

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 * NOTE: If the patient had an orchiectomy prior to registration, report tumor marker values before and after surgery on the Baseline Tumor Marker form

Patients must have risk of relapse assessment determined by the local investigator prior to registration

Patients must agree to submit required specimens for defined translational medicine studies. These specimens are drawn at the same time as standard laboratory evaluations (beta-HCG, AFP, and LDH); NOTE: Ideally, patients should be willing to return to their center performing surveillance (registering site) for the duration of the study to ensure that specimens are timed to standard clinical observations (the registering site’s surveillance schedule)

Patients must be offered participation in specimen banking for future research. With patient’s consent, specimens must be submitted.

Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

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