ULTRA-high-risk Surveillance to Avoid Future Events: the ULTRA-SAFE Trial (NCT07378930) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
ULTRA-high-risk Surveillance to Avoid Future Events: the ULTRA-SAFE Trial
940 participantsStarted 2026-03-01
Plain-language 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.
Who can participate
Age range40 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
✕. Adenoma Count/Type: Failure to meet the requirement of at least two advanced adenomas during the initial colonoscopy.