CClinicalTrials.gg
Active, not recruitingNCT04435756Updated Mar 12, 2026

A Study of miRNA 371 in Patients With Germ Cell Tumors

An observational study in Germ Cell Tumor, Metachronous Malignant Neoplasm and Seminoma, sponsored by SWOG Cancer Research Network. Active, not recruiting at 424 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by SWOG Cancer Research Network · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
956
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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 cell malignancy.

SECONDARY OBJECTIVES:

I. To bank prospectively obtained serial liquid biospecimens for low and moderate risk of relapse patients annotated by patient level clinical data.

II. To bank prospectively collected, clinically annotated specimens for high risk patients and non-testicular primary patients in collaboration with Children's Oncology Group study AGCT 1531.

OUTLINE:

Patients undergo collection of blood every 3-6 months for up to 3 years.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with newly diagnosed germ cell tumor

Eligibility criteria

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
956 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Observational (blood collection)

    Patients undergo collection of blood every 3-6 months for up to 3 years.

    Other: Biomarker Analysis · Procedure: Blood Product Collection

Interventions

  • OtherBiomarker Analysis

    Correlative study

  • ProcedureBlood Product Collection

    Undergo collection of blood

    Also known as: Collection, Blood Products

05

What researchers measure

Primary outcomes

  1. To estimate positive predictive value of miRNA 371 in early stage testicular seminoma and nonseminoma patients

    Positive predictive value will be estimated using plasma miRNA 371 expression at relapse.

    Time frame: Up to 3 years

  2. To bank blood specimens of patients at low risk and moderate risk of relapse

    10 ml whole blood will be collected at time points specified by the protocol.

    Time frame: Up to 3 years

06

Study locations

424 sites
  • Banner MD Anderson Cancer Center
    Gilbert, Arizona 85234, United States
  • Kingman Regional Medical Center
    Kingman, Arizona 86401, United States
  • University of Arizona Cancer Center-Orange Grove Campus
    Tucson, Arizona 85704, United States
  • Banner University Medical Center - Tucson
    Tucson, Arizona 85719, United States
  • University of Arizona Cancer Center-North Campus
    Tucson, Arizona 85719, United States
  • Mercy Hospital Fort Smith
    Fort Smith, Arkansas 72903, United States
  • Kaiser Permanente-Anaheim
    Anaheim, California 92806, United States
  • Kaiser Permanente-Deer Valley Medical Center
    Antioch, California 94531, United States
  • PCR Oncology
    Arroyo Grande, California 93420, United States
  • Kaiser Permanente-Baldwin Park
    Baldwin Park, California 91706, United States
  • Kaiser Permanente-Bellflower
    Bellflower, California 90706, United States
  • Keck Medicine of USC Buena Park
    Buena Park, California 90621, United States
  • Epic Care-Dublin
    Dublin, California 94568, United States
  • Kaiser Permanente Dublin
    Dublin, California 94568, United States
  • Bay Area Breast Surgeons Inc
    Emeryville, California 94608, United States
  • Epic Care Partners in Cancer Care
    Emeryville, California 94608, United States
  • Kaiser Permanente-Fontana
    Fontana, California 92335, United States
  • Kaiser Permanente-Fremont
    Fremont, California 94538, United States
  • Fresno Cancer Center
    Fresno, California 93720, United States
  • Kaiser Permanente-Fresno
    Fresno, California 93720, United States
  • Kaiser Permanente - Harbor City
    Harbor City, California 90710, United States
  • Keck Medicine of USC Huntington Beach
    Huntington Beach, California 92648, United States
  • Kaiser Permanente-Irvine
    Irvine, California 92618, United States
  • UC San Diego Moores Cancer Center
    La Jolla, California 92093, United States
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
  • Keck Medicine of USC Koreatown
    Los Angeles, California 90020, United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California 90027, United States
  • Los Angeles County-USC Medical Center
    Los Angeles, California 90033, United States
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
  • Kaiser Permanente West Los Angeles
    Los Angeles, California 90034, United States
  • UCLA / Jonsson Comprehensive Cancer Center
    Los Angeles, California 90095, United States
  • Contra Costa Regional Medical Center
    Martinez, California 94553-3156, United States
  • Kaiser Permanente-Modesto
    Modesto, California 95356, United States
  • UCI Health Newport -- Birch Street
    Newport Beach, California 92660, United States
  • USC Norris Oncology/Hematology-Newport Beach
    Newport Beach, California 92663, United States
  • Alta Bates Summit Medical Center - Summit Campus
    Oakland, California 94609, United States
  • Bay Area Tumor Institute
    Oakland, California 94609, United States
  • Kaiser Permanente Oakland-Broadway
    Oakland, California 94611, United States
  • Kaiser Permanente-Oakland
    Oakland, California 94611, United States
  • Kaiser Permanente-Ontario
    Ontario, California 91761, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange, California 92868, United States
  • Kaiser Permanente - Panorama City
    Panorama City, California 91402, United States
  • Keck Medical Center of USC Pasadena
    Pasadena, California 91105, United States
  • Kaiser Permanente-Rancho Cordova Cancer Center
    Rancho Cordova, California 95670, United States
  • Kaiser Permanente- Marshall Medical Offices
    Redwood City, California 94063, United States
  • Kaiser Permanente-Redwood City
    Redwood City, California 94063, United States
  • Kaiser Permanente-Richmond
    Richmond, California 94801, United States
  • Kaiser Permanente-Riverside
    Riverside, California 92505, United States
  • Rohnert Park Cancer Center
    Rohnert Park, California 94928, United States
  • Kaiser Permanente-Roseville
    Roseville, California 95661, United States
  • The Permanente Medical Group-Roseville Radiation Oncology
    Roseville, California 95678, United States
  • Kaiser Permanente Downtown Commons
    Sacramento, California 95814, United States
  • Kaiser Permanente-South Sacramento
    Sacramento, California 95823, United States
  • South Sacramento Cancer Center
    Sacramento, California 95823, United States
  • UC San Diego Medical Center - Hillcrest
    San Diego, California 92103, United States
  • Kaiser Permanente-San Diego Mission
    San Diego, California 92108, United States
  • Kaiser Permanente-San Diego Zion
    San Diego, California 92120, United States
  • Kaiser Permanente-San Francisco
    San Francisco, California 94115, United States
  • Kaiser Permanente-Santa Teresa-San Jose
    San Jose, California 95119, United States
  • Kaiser Permanente San Leandro
    San Leandro, California 94577, United States
  • Kaiser Permanente-San Marcos
    San Marcos, California 92078, United States
  • Kaiser San Rafael-Gallinas
    San Rafael, California 94903, United States
  • Kaiser Permanente Medical Center - Santa Clara
    Santa Clara, California 95051, United States
  • Kaiser Permanente-Santa Rosa
    Santa Rosa, California 95403, United States
  • Kaiser Permanente Cancer Treatment Center
    South San Francisco, California 94080, United States
  • Kaiser Permanente-South San Francisco
    South San Francisco, California 94080, United States
  • Kaiser Permanente-Stockton
    Stockton, California 95210, United States
  • Kaiser Permanente Medical Center-Vacaville
    Vacaville, California 95688, United States
  • Kaiser Permanente-Vallejo
    Vallejo, California 94589, United States
  • Kaiser Permanente-Walnut Creek
    Walnut Creek, California 94596, United States
  • Epic Care Cyberknife Center
    Walnut Creek, California 94597, United States
  • Kaiser Permanente-Woodland Hills
    Woodland Hills, California 91367, United States
  • University of Colorado Hospital
    Aurora, Colorado 80045, United States
  • Poudre Valley Hospital
    Fort Collins, Colorado 80524, United States
  • Cancer Care and Hematology-Fort Collins
    Fort Collins, Colorado 80528, United States
  • UCHealth Greeley Hospital
    Greeley, Colorado 80631, United States
  • UCHealth Highlands Ranch Hospital
    Highlands Ranch, Colorado 80129, United States
  • Medical Center of the Rockies
    Loveland, Colorado 80538, United States
  • Beebe South Coastal Health Campus
    Frankford, Delaware 19945, United States
  • Beebe Medical Center
    Lewes, Delaware 19958, United States
  • Delaware Clinical and Laboratory Physicians PA
    Newark, Delaware 19713, United States
  • Helen F Graham Cancer Center
    Newark, Delaware 19713, United States
  • Medical Oncology Hematology Consultants PA
    Newark, Delaware 19713, United States
  • Christiana Care Health System-Christiana Hospital
    Newark, Delaware 19718, United States
  • Beebe Health Campus
    Rehoboth Beach, Delaware 19971, United States
  • Christiana Care Health System-Wilmington Hospital
    Wilmington, Delaware 19801, United States
  • Hawaii Cancer Care Inc - Waterfront Plaza
    Honolulu, Hawaii 96813, United States
  • Island Urology
    Honolulu, Hawaii 96813, United States
  • Queen's Cancer Cenrer - POB I
    Honolulu, Hawaii 96813, United States
  • Queen's Medical Center
    Honolulu, Hawaii 96813, United States
  • Straub Clinic and Hospital
    Honolulu, Hawaii 96813, United States
  • University of Hawaii Cancer Center
    Honolulu, Hawaii 96813, United States
  • Hawaii Cancer Care Inc-Liliha
    Honolulu, Hawaii 96817, United States
  • Hawaii Diagnostic Radiology Services LLC
    Honolulu, Hawaii 96817, United States
  • Kuakini Medical Center
    Honolulu, Hawaii 96817, United States
  • Queen's Cancer Center - Kuakini
    Honolulu, Hawaii 96817, United States
  • The Cancer Center of Hawaii-Liliha
    Honolulu, Hawaii 96817, United States
  • Kaiser Permanente Moanalua Medical Center
    Honolulu, Hawaii 96819, United States
  • Kapiolani Medical Center for Women and Children
    Honolulu, Hawaii 96826, United States
  • Straub Medical Center - Kahului Clinic
    Kahului, Hawaii 96732, United States

Showing the first 100 of 424 sites across 3 countries.

07

Registry details

Key details

Study ID
NCT04435756
Lead sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 17, 2020
Start date
Jul 28, 2020
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Mar 12, 2026

Study contacts

Craig R Nichols
principal investigator · SWOG Cancer Research Network

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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