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A Study of miRNA 371 in Patients With Germ Cell Tumors

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ClinicalTrials.gov Identifier: NCT04435756
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : January 5, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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

Condition or disease Intervention/treatment
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 Other: Biomarker Analysis Procedure: Blood Product Collection

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 956 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients With Newly Diagnosed Germ Cell Tumors
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 1, 2025

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Observational (blood collection)
Patients undergo collection of blood every 3-6 months for up to 3 years.
 Other: Biomarker Analysis
Correlative study

Procedure: Blood Product Collection
Undergo collection of blood
Other Name: Collection, Blood Products


Outcome Measures
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Primary Outcome Measures :
  1. To estimate positive predictive value of miRNA 371 in early stage testicular seminoma and nonseminoma patients [ Time Frame: Up to 3 years ]
    Positive predictive value will be estimated using plasma miRNA 371 expression at relapse.

  2. To bank blood specimens of patients at low risk and moderate risk of relapse [ Time Frame: Up to 3 years ]
    10 ml whole blood will be collected at time points specified by the protocol.


Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with newly diagnosed germ cell tumor
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435756


Contacts
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Contact: Patricia O'Kane 210-614-8808 pokane@swog.org
Contact: Dana Sparks, MAT 210-614-8808 ext 1004 dsparks@swog.org

Locations
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Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Craig R Nichols Southwest Oncology Group
More Information
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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT04435756    
Other Study ID Numbers: S1823
NCI-2019-06177 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S1823 ( Other Identifier: SWOG )
SWOG-S1823 ( Other Identifier: DCP )
S1823 ( Other Identifier: CTEP )
UG1CA189974 ( U.S. NIH Grant/Contract )
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Neoplasms
Seminoma
Testicular Neoplasms
Neoplasms by Histologic Type
Germinoma
Endocrine Gland Neoplasms
 Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders