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 range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on ultra-high-risk patients for colorectal cancer — how would my doctor determine whether I fall into that category, and would I even be a candidate to discuss this trial when it opens?
2Since the trial isn't recruiting yet, what is my doctor recommending for my colorectal surveillance in the meantime, and would waiting potentially affect my care?
3The trial is measuring the 3-year rate of new advanced colorectal lesions after an initial finding — can my doctor explain what 'metachronous advanced colorectal neoplasia' means for someone in my situation and why that timeframe matters?
4Because this study has no listed phase and appears to be a surveillance strategy trial rather than a drug trial, can my doctor clarify what the actual intervention being studied is — for example, is it a different colonoscopy schedule, a new detection technique, or something else?
5Are there established standard-of-care surveillance guidelines my doctor already follows for high-risk colorectal patients, and how would joining this trial differ from or potentially conflict with that standard approach?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.