ULTRA-high-risk Surveillance to Avoid Future Events: the ULTRA-SAFE Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorNational Taiwan University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age: Adults aged 40 to 75 years.
Initial Colonoscopy Findings: Detection and removal of at least two advanced adenomas during the baseline colonoscopy.
Adherence: Willingness to comply with the assigned screening protocol, including fecal immunochemical testing (FIT) and follow-up colonoscopies
Disqualifiers
Age: Individuals younger than 40 or older than 75 years.
High-Risk Predispositions: Patients with inflammatory bowel disease (IBD), Familial Adenomatous Polyposis (FAP), or a documented hereditary colorectal cancer syndrome (e.g., Lynch syndrome).
Cancer History: A history of colorectal cancer (excluding carcinoma in situ).
Contraindications: Patients for whom polypectomy is clinically inappropriate or unsafe.
Trial design
Design model
Parallel
Treatments tested in this trial
Early triage using Fecal immunochemical test
Diagnostic testFecal 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
Treatment groups
940 Participants
are divided into 2 treatment groupsGroup A: Standard care armNo intervention 0 interventions
Group B: FIT armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
3-year incidence of metachronous ACRN
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
Time frame
three years after recuitmentSecondary outcomes
1
Overall incidence of metachronous ACRN
The incidence of metachronous advanced colorectal neoplasm (adenoma larger than 1cm OR with villous components OR with high-grade dysplasia OR colorectal cancert) at the surveillance colonoscopy at third year in standard-care arm and all surveillance colonoscopy in FIT arm
Time frame
3 years after recruitment2
Overall incidence of metachronous colorectal cancer
The incidence of metachronous colorectal cancer at the surveillance colonoscopy at third year in standard-care arm and all surveillance colonoscopy in FIT arm
Time frame
three years after recuitmentSponsors and contacts
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Source ClinicalTrials.gov