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ACTIVE NOT RECRUITING

NCT04435756

A Study of miRNA 371 in Patients With Germ Cell Tumors

Sponsor: SWOG Cancer Research Network

View on ClinicalTrials.gov

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 with germ cell cancers in the laboratory may help doctors predict how likely the cancer will come back.

Official title: A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients With Newly Diagnosed Germ Cell Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

956

Start Date

2020-07-28

Completion Date

2028-01-01

Last Updated

2026-03-12

Healthy Volunteers

Conditions

Germ Cell Tumor Metachronous Malignant Neoplasm Seminoma Stage I Testicular Cancer AJCC v8 Stage IA Testicular Cancer AJCC v8 Stage IB Testicular Cancer AJCC v8 Stage IS Testicular Cancer AJCC v8

Interventions

OTHER

Biomarker Analysis

Correlative study

PROCEDURE

Blood Product Collection

Undergo collection of blood

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

Locations (424)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Kingman Regional Medical Center

Kingman, Arizona, United States

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

Kaiser Permanente-Anaheim

Anaheim, California, United States

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

PCR Oncology

Arroyo Grande, California, United States

Kaiser Permanente-Baldwin Park

Baldwin Park, California, United States

Kaiser Permanente-Bellflower

Bellflower, California, United States

Keck Medicine of USC Buena Park

Buena Park, California, United States

Epic Care-Dublin

Dublin, California, United States

Kaiser Permanente Dublin

Dublin, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

Kaiser Permanente-Fontana

Fontana, California, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Fresno Cancer Center

Fresno, California, United States

Kaiser Permanente-Fresno

Fresno, California, United States

Kaiser Permanente - Harbor City

Harbor City, California, United States

Keck Medicine of USC Huntington Beach

Huntington Beach, California, United States

Kaiser Permanente-Irvine

Irvine, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Keck Medicine of USC Koreatown

Los Angeles, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Los Angeles County-USC Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Kaiser Permanente West Los Angeles

Los Angeles, California, United States

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Kaiser Permanente-Modesto

Modesto, California, United States

UCI Health Newport -- Birch Street

Newport Beach, California, United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Kaiser Permanente-Ontario

Ontario, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Kaiser Permanente - Panorama City

Panorama City, California, United States

Keck Medical Center of USC Pasadena

Pasadena, California, United States

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

Kaiser Permanente- Marshall Medical Offices

Redwood City, California, United States

Kaiser Permanente-Redwood City

Redwood City, California, United States

Kaiser Permanente-Richmond

Richmond, California, United States

Kaiser Permanente-Riverside

Riverside, California, United States

Rohnert Park Cancer Center

Rohnert Park, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Kaiser Permanente Downtown Commons

Sacramento, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

South Sacramento Cancer Center

Sacramento, California, United States

UC San Diego Medical Center - Hillcrest

San Diego, California, United States

Kaiser Permanente-San Diego Mission

San Diego, California, United States

Kaiser Permanente-San Diego Zion

San Diego, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

Kaiser Permanente-San Marcos

San Marcos, California, United States

Kaiser San Rafael-Gallinas

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Kaiser Permanente-Stockton

Stockton, California, United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Epic Care Cyberknife Center

Walnut Creek, California, United States

Kaiser Permanente-Woodland Hills

Woodland Hills, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

UCHealth Greeley Hospital

Greeley, Colorado, United States

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Beebe South Coastal Health Campus

Frankford, Delaware, United States

Beebe Medical Center

Lewes, Delaware, United States

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Hawaii Cancer Care Inc - Waterfront Plaza