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

Sponsor: National Taiwan University Hospital • ClinicalTrials.gov ID: NCT07378930

Registry updated: 2026-08-26

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Description

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.

Interventions

Early triage using Fecal immunochemical test (Diagnostic 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

Eligibility criteria

Inclusion Criteria: 1. Age: Adults aged 40 to 75 years. 2. Initial Colonoscopy Findings: Detection and removal of at least two advanced adenomas during the baseline colonoscopy. 3. Adherence: Willingness to comply with the assigned screening protocol, including fecal immunochemical testing (FIT) and follow-up colonoscopies Exclusion Criteria: 1. Age: Individuals younger than 40 or older than 75 years. 2. High-Risk Predispositions: Patients with inflammatory bowel disease (IBD), Familial Adenomatous Polyposis (FAP), or a documented hereditary colorectal cancer syndrome (e.g., Lynch syndrome). 3. Cancer History: A history of colorectal cancer (excluding carcinoma in situ). 4. Contraindications: Patients for whom polypectomy is clinically inappropriate or unsafe. 5. Adenoma Count/Type: Failure to meet the requirement of at least two advanced adenomas during the initial colonoscopy. 7.Extensive Low-Risk Lesions: Presence of more than ten low-risk adenomas. 8.Pregnancy: Currently pregnant individuals.

Conditions

Colorectal Neoplasms Colorectal Cancer Prevention Surveillance Colonoscopy

Locations

National Taiwan University Hospital — Taipei, Taipei, Taiwan
National Taiwan University Hospital Hsinchu Branch — Hsinchu, Taiwan
Fu Jen Catholic University Hospital — New Taipei City, Taiwan
National Taiwan University Cancer Center — Taipei, Taiwan

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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