Clinical Trial

ULTRA-high-risk Surveillance to Avoid Future Events: the ULTRA-SAFE Trial

Study acronym: ULTRA-SAFE
Not Yet Recruiting
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Summary
The ULTRA-SAFE clinical trial is a prospective, randomized study designed to address the limitations of current "one-size-fits-all" colorectal cancer surveillance guidelines. While international standards recommend a three-year follow-up colonoscopy for all high-risk patients, data suggests that those with multiple advanced adenomas face a significantly higher recurrence risk (20%) compared to those with only low-risk adenomas (9%). To provide more personalized care, the trial compares a Standard Arm (colonoscopy at year three) against a FIT Arm, where participants undergo annual fecal immunochemical testing in years one and two. A positive FIT triggers an earlier colonoscopy, with the goal of reducing the 3-year prevalence of metachronous advanced colorectal neoplasms (meta-ACRN) from 20% to approximately 12.7%. The study has enrolled roughly 940 participants to statistically validate whether this early screening intervention can effectively prevent future malignant events in ultra-high-risk populations.
Trial Details
NCT Number NCT07378930
Lead Sponsor National Taiwan University Hospital
Conditions Colorectal Neoplasms, Colorectal Cancer Prevention, Surveillance Colonoscopy
Enrollment 940 participants
Start Date 2026-03-01
Primary Completion 2028-03-01 (estimated)
Study Completion 2031-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-30