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.
Eligibility
Inclusion Criterea
- 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 be >= 18 years of age. NOTE: patients less than 18 years of age should be considered for direct enrollment in COG AGCT 1531.
- 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
Participating Clinics
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
University Medical Center of Southern Nevada
Hope Cancer Care of Nevada
Saint Mary's Regional Medical Center
OptumCare Cancer Care at MountainView
Comprehensive Cancer Centers of Nevada - Town Center
Comprehensive Cancer Centers of Nevada-Summerlin
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Las Vegas Cancer Center-Henderson
GenesisCare USA - Henderson
GenesisCare USA - Las Vegas
Renown Regional Medical Center
Comprehensive Cancer Centers of Nevada - Henderson
Carson Tahoe Regional Medical Center
OptumCare Cancer Care at Fort Apache
Summerlin Hospital Medical Center
Comprehensive Cancer Centers of Nevada - Northwest
GenesisCare USA - Vegas Tenaya
GenesisCare USA - Fort Apache
Kingman Regional Medical Center
Las Vegas Cancer Center-Medical Center
Radiation Oncology Centers of Nevada Central
Radiation Oncology Associates
Comprehensive Cancer Centers of Nevada
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Cancer and Blood Specialists-Henderson
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Sunrise Hospital and Medical Center
Radiation Oncology Centers of Nevada Southeast
Hope Cancer Care of Nevada-Pahrump
OptumCare Cancer Care at Charleston
Comprehensive Cancer Centers of Nevada - Central Valley
OptumCare Cancer Care at Seven Hills
Las Vegas Prostate Cancer Center
Las Vegas Urology - Sunset
Las Vegas Urology - Cathedral Rock
Las Vegas Urology - Pebble
Las Vegas Urology - Pecos
Las Vegas Urology - Green Valley
Urology Specialists of Nevada - Green Valley
Urology Specialists of Nevada - Central
Urology Specialists of Nevada - Southwest
Urology Specialists of Nevada - Northwest