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 : December 12, 2023
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Tracking Information | |||||||||
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First Submitted Date | June 15, 2020 | ||||||||
First Posted Date | June 17, 2020 | ||||||||
Last Update Posted Date | December 12, 2023 | ||||||||
Actual Study Start Date | July 28, 2020 | ||||||||
Estimated Primary Completion Date | June 1, 2026 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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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. |
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Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Retention: Samples With DNA Description: Blood
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Sampling Method | Probability Sample | ||||||||
Study Population | Patients with newly diagnosed germ cell tumor | ||||||||
Condition |
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Intervention |
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Study Groups/Cohorts | Observational (blood collection)
Patients undergo collection of blood every 3-6 months for up to 3 years.
Interventions:
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
956 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | October 1, 2026 | ||||||||
Estimated Primary Completion Date | June 1, 2026 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria | Inclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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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 ) |
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Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement | Not Provided | ||||||||
Current Responsible Party | SWOG Cancer Research Network | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor | SWOG Cancer Research Network | ||||||||
Original Study Sponsor | Same as current | ||||||||
Collaborators | National Cancer Institute (NCI) | ||||||||
Investigators |
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PRS Account | SWOG Cancer Research Network | ||||||||
Verification Date | December 2023 |