Status:
ACTIVE_NOT_RECRUITING
A Study of MiRNA 371 in Patients with Germ Cell Tumors
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Germ Cell Tumor
Metachronous Malignant Neoplasm
Eligibility:
All Genders
18+ years
Brief Summary
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 wi...
Detailed Description
PRIMARY OBJECTIVE: I. To estimate the positive predictive value within each of the early stage testicular seminoma and nonseminoma groups using plasma miRNA 371 expression at relapse to detect germ c...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 28 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
956 Patients enrolled
Trial Details
Trial ID
NCT04435756
Start Date
July 28 2020
End Date
January 1 2028
Last Update
February 26 2025
Active Locations (424)
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1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
Kingman Regional Medical Center
Kingman, Arizona, United States, 86401
3
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, United States, 85704
4
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719