Clinical trial · Interventional
IBD Neoplasia Surveillance Pilot RCT
A Randomized, Parallel-Group, Non-Inferiority Trial Comparing Random AND Targeted Biopsies to Targeted Biopsies Alone for Neoplasia Screening in Adult Persons With Colonic Inflammatory Bowel Diseases: A Pilot Study
- 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)
To determine if random biopsies can be safely eliminated from screening of average risk persons with IBD, the investigators propose to carry out a pilot randomized control trial in which targeted biopsies in combination with random biopsies will be compared to targeted biopsies alone in terms of pre-cancerous lesion capture rate, side-effects and CRC risk. The pilot study will aim to capture 20% of the overall study population in order to evaluate the feasibility of recruiting the needed number of participants in the specified time frame, while maintaining high quality of data collection.
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 |
|---|---|---|---|
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
| Dysplasia | — | UNRESOLVED | — |
| Inflammatory Bowel Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control Group | Diagnostic Test | — | UNRESOLVED |
| Intervention Group | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy targeted biopsies (biopsies of any pre-cancerous lesions observed by the doctor) and/or removal of any polyps will be undertaken.
- interventionNames
- Diagnostic Test: Intervention Group
- type
- OTHER
- label
- Control Group
- description
- Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy both random (approximately 32 to 40) and targeted biopsies (and/or removal of any polyps) will be undertaken.
- interventionNames
- Diagnostic Test: Control Group
Primary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 years old * Historical endoscopic/histologic disease extending beyond the rectum in UC or involving ≥ 1/3 of colorectum in CD * \> 50% of colon present, with remaining colon meeting above minimum criteria for disease extent (beyond rectum in UC, ≥1/3 colorectum in CD * cIBD ≥ 8 years duration (or at any time after diagnosis if a patient also has primary sclerosing cholangitis) * In symptomatic remission at time of colonoscopy * For CD: Harvey-Bradshaw Index \< 541 * For UC or IBDU: Partial Mayo Score ≤ 242 * Major purpose of colonoscopy is neoplasia screening/surveillance * Undergoing colonoscopy with high-definition white light endoscopy Exclusion Criteria: * Persons who cannot or are unwilling to provide informed consent * Persons with a history of colorectal cancer * Persons with prior subtotal or total colectomy (\> 50% of colon removed) * Persons undergoing colonoscopy to follow-up on recently diagnosed neoplasia identified within the past year * Persons undergoing pancolonic chromoendoscopy * Colon mucosa visibility deemed inadequate for surveillance after washing/suctioning (Boston Bowel Preparation Score of 0 or 1 in any segment) * Incomplete colonoscopy (unable to reach cecum) * Moderate-to-severe inflammation (Mayo 2-3) involving ≥ 25% of colorectum or mild inflammation (Mayo 1) involving ≥ 50% of colorectum
References
Publications (1)
- DERIVEDMurthy SK, Marderfeld L, Fergusson D, Ramsay T, Bernstein CN, Nguyen GC, Jairath V, Riddell R. A randomized trial evaluating the utility of non-targeted biopsies for colorectal neoplasia detection in adults with inflammatory bowel disease: a pilot study protocol. Pilot Feasibility Stud. 2024 Feb 1;10(1):20. doi: 10.1186/s40814-023-01434-8. PMID 38297397