NCT07378930 ULTRA-high-risk Surveillance to Avoid Future Events: the ULTRA-SAFE Trial
| NCT ID | NCT07378930 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Colorectal Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 940 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 940 participants in total. It began in 2026-07-01 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07378930 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Colorectal Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07378930 currently recruiting?
Yes, NCT07378930 is actively recruiting participants. Contact the research team at wychang1005@gmail.com for enrollment information.
Where is the NCT07378930 trial being conducted?
This trial is being conducted at Taipei, Taiwan, Hsinchu, Taiwan, New Taipei City, Taiwan, Taipei, Taiwan.
Who is sponsoring the NCT07378930 clinical trial?
NCT07378930 is sponsored by National Taiwan University Hospital. The trial plans to enroll 940 participants.