NCT07378930Recruiting
ULTRA-high-risk Surveillance to Avoid Future Events: the ULTRA-SAFE Trial
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 940 (estimated)
- First submitted
- 23 Jan 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Mar 2028
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07378930
What you commit to
- Study type: Interventional
- Planned participants: 940
- From 1 Jul 2026 to the primary completion date, 1 Mar 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Lab values
- 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
- Age: Individuals younger than 40 or older than 75 years.
Other
- Contraindications: Patients for whom polypectomy is clinically inappropriate or unsafe.
Who the study is looking for
- 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
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital - Hsinchu branch Coordinator of this site? Confirm its status | Hsinchu | Taiwan | Recruiting |
| Fu Jen Catholic University Hospital Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| National Taiwan University Cancer Center Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.