Clinical trial · Interventional
ULTRA-high-risk Surveillance to Avoid Future Events: the ULTRA-SAFE Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Prevention | — | UNRESOLVED | — |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Surveillance Colonoscopy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early triage using Fecal immunochemical test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard care arm
- description
- Surveillance colonoscopy performed at third year after initial colonoscopy
- type
- EXPERIMENTAL
- label
- FIT arm
- description
- Intervention: Early triage using Fecal immunochemical test Detailed: Participants in this group will undergo Fecal Immunochemical Testing (FIT) in the first and second years (FIT 1 \& 2) following their initial colonoscopy. If FIT 1 is positive, a colonoscopy will be scheduled within three months; regardless of those findings, a surveillance colonoscopy is still required in the third year. If FIT 1 is negative, the patient proceeds to FIT 2 in the second year. A positive FIT 2 likewise triggers a colonoscopy within three months, and a third-year surveillance colonoscopy remains mandatory unless the FIT 2-triggered colonoscopy occurs between 2.5 and 3.5 years after the initial procedure, in which case it fulfills the third-year requirement. If both FIT 1 and FIT 2 are negative, the participant will undergo their scheduled surveillance colonoscopy in the third year.
- interventionNames
- Diagnostic Test: Early triage using Fecal immunochemical test
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available