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Clinical trial Recruiting at 4 sites Interventional Ages 40 to 75

ULTRA-SAFE: Personalize colorectal cancer surveillance using annual FIT with optional earlier colonoscopy

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

Run by National Taiwan University Hospital · NCT07378930 · Data updated 2026-11-12

This trial tests whether annual fecal immunochemical testing (FIT) with earlier colonoscopy on positive results is better than a fixed colonoscopy at three years for people at very high risk after removing multiple advanced adenomas.

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Quick facts

Study typeInterventional
Ages40 Years to 75 Years
SexAll
Enrollment940 (estimated)
SponsorNational Taiwan University Hospital
Academic / other
Locations4 sites (Taipei, Taipei and 3 other locations)
StatusRecruiting
StartedJuly 1, 2026
Main results expectedMarch 1, 2028
Study endsMay 1, 2031
Registry record updatedAugust 26, 2026
Trial IDNCT07378930 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 40 to 75 who had at least two advanced adenomas removed at baseline colonoscopy and are willing to follow the assigned surveillance protocol.

Probably not a fit

Patients over 75, under 40, with certain hereditary conditions or prior colorectal cancer, or those unable to adhere to FIT/colonoscopy follow-up may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ULTRA-SAFE is a randomized study comparing two strategies for post-polypectomy surveillance in ultra-high-risk individuals. One arm follows standard care with a colonoscopy at year three. The other uses yearly FITs in years one and two, with an early colonoscopy if the test is positive, aiming to reduce recurrent advanced colorectal neoplasms. The trial seeks to personalize follow-up by using noninvasive testing to trigger earlier endoscopic assessment when risk is highest. About 940 participants have been enrolled to determine if this approach can lower the 3-year risk of metachronous advanced lesions. Colorectal cancer prevention hinges on timely detection and removal of high-risk lesions, and this study targets those with multiple advanced adenomas or high-risk features identified on initial colonoscopy.

Why it matters

Potential benefit: If successful, the approach could reduce the rate of metachronous advanced colorectal neoplasms and spare some patients from unnecessary colonoscopies while ensuring high-risk individuals are identified earlier.

How similar studies have gone: Prior data suggest risk-based, noninvasive screening can help tailor surveillance, but this exact FIT-triggered approach in ultra-high-risk groups is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

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

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.