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

Condition(s) studied

Investigational drug(s) / intervention(s)

Early triage using Fecal immunochemical test: Fecal immunochemical test would be provided at first and second year after initial colonoscopy in FIT arm. Those with positive results would be arranged with early surveillance colonoscopy

Study 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.

Eligibility

Primary outcome measure(s)

• 3-year incidence of metachronous ACRN — three years after recuitment
  The incidence of metachronous advanced colorectal neoplasm (ACRN: adenoma larger than 1cm OR with villous components OR with high-grade dysplasia OR colorectal cancer) at third-year surveillance colonoscopy in both arms

Trial sites (4)

More National Taiwan University Hospital trials in Taiwan

Other trials for the same condition