NCT04435756

A Study of miRNA 371 in Patients With Germ Cell Tumors

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 956 (estimated)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
OTHER	Biomarker Analysis	Correlative study
PROCEDURE	Blood Product Collection	Undergo collection of blood

Timeline

• Start date: 2020-07-28
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2020-06-17
• Last updated: 2026-03-12

Locations

424 sites across 3 countries: United States, Canada, Guam