A Study of miRNA 371 in Patients With Germ Cell Tumors

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Brief Title

A Study of miRNA 371 in Patients With Germ Cell Tumors

Official Title

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

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.
    

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 Type

Observational


Primary Outcome

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


Condition

Germ Cell Tumor

Intervention

Biomarker Analysis

Study Arms / Comparison Groups

 Observational (blood collection)
Description:  Patients undergo collection of blood every 3-6 months for up to 3 years.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

956

Start Date

June 1, 2020

Completion Date

April 1, 2025

Primary Completion Date

April 1, 2025

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Craig R Nichols, 210-614-8808, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT04435756

Organization ID

S1823

Secondary IDs

NCI-2019-06177

Responsible Party

Sponsor

Study Sponsor

Southwest Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Craig R Nichols, Principal Investigator, Southwest Oncology Group


Verification Date

February 2021