Yearly stool blood tests to guide follow-up colonoscopy after high-risk colorectal polyps
Tests yearly stool blood tests before colonoscopy in people with high-risk colorectal polyps.
Plain-language title generated from the registry record
Registry title: ULTRA-high-risk Surveillance to Avoid Future Events: the ULTRA-SAFE Trial
Key facts
- Where
- Hsinchu, New Taipei City, and Taipei, TaiwanSee the 4 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 75 years old?
Source: NCT07378930, who can take part
Where in Taiwan
- National Taiwan University Hospital - Hsinchu branchHsinchu, TaiwanTaking people
- Fu Jen Catholic University HospitalNew Taipei City, TaiwanTaking people
- National Taiwan University Cancer CenterTaipei, TaiwanTaking people
- National Taiwan University HospitalTaipei, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Taiwan University Hospital
- Trial code
- NCT07378930
- Record updated
- 26 August 2026
- Original 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.Read full original descriptionShow less
ULTRA-high-risk Surveillance to Avoid Future Events: the ULTRA-SAFE 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.
Inclusion: 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: 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); 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; Age: Individuals younger than 40 or older than 75 years; Contraindications: Patients for whom polypectomy is clinically inappropriate or unsafe.