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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

Tracking Information
First Submitted Date June 15, 2020
First Posted Date June 17, 2020
Last Update Posted Date January 5, 2021
Actual Study Start Date June 1, 2020
Estimated Primary Completion Date April 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 29, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: June 15, 2020)
  • Relapse rate of active germ cell malignancy for those undergoing active surveillance of clinical stage I (CSI)/stage IIA germ cell malignancy [ Time Frame: Up to 3 years ]
  • Positive predictive value [ Time Frame: Up to 3 years ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood
Sampling Method Probability Sample
Study Population Patients with newly diagnosed germ cell tumor
Condition
  • 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
Intervention
  • Other: Biomarker Analysis
    Correlative study
  • Procedure: Blood Product Collection
    Undergo collection of blood
    Other Name: Collection, Blood Products
Study Groups/Cohorts Observational (blood collection)
Patients undergo collection of blood every 3-6 months for up to 3 years.
Interventions:
  • Other: Biomarker Analysis
  • Procedure: Blood Product Collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 15, 2020)
956
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 1, 2025
Estimated Primary Completion Date April 1, 2025   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Patricia O'Kane 210-614-8808 pokane@swog.org
Contact: Dana Sparks, MAT 210-614-8808 ext 1004 dsparks@swog.org
Listed Location Countries Canada,   Guam,   United States
Removed Location Countries  
 
Administrative Information
NCT Number 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Southwest Oncology Group
Study Sponsor Southwest Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Craig R Nichols Southwest Oncology Group
PRS Account Southwest Oncology Group
Verification Date December 2020