Clinical Trial

Collection of Samples USOPTIVAL Study

Recruiting
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Record status
This record was last updated November 10, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
A prospective multi-center observational study. The study will enroll eligible subjects from the United States to optimize the biomarker panel and evaluate the performance of a cfDNA marker panel selected by the Sponsor for CRC and advanced adenoma detection.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2021-03-08; most recent amendment 2025-11-05.
Trial Details
NCT Number NCT04792684
Lead Sponsor Universal Diagnostics
Conditions Colorectal Cancer (CRC), Advanced Adenomas (AA)
Enrollment 1,300 participants
Start Date 2020-12-30
Primary Completion 2025-12-30 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-11-10