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

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

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.

Conditions4

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