Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study

NCT07719426 | Not Yet Recruiting

• 1 other identifier: 2025-A02237-42
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

Inflammatory Bowel Disease (IBD) patients have an increased risk of ColoRectal Cancer (CRC). The cumulative risk of CRC development is estimated at 1% after 10 years of disease progression, 2% after 20 years, and 5% after more than 20 years of disease progression (1). The incidence of CRC in IBD has gradually declined, attributed to enhanced detection of preneoplastic lesions (dysplasia), improved adherence to screening recommendations, utilization of advanced high-definition endoscopes (2-4), and the implementation of more efficacious therapeutic strategies (5-9). Presently, there is no consensus on the endoscopic management of dysplastic lesions. Recent techniques such as submucosal dissection (ESD) enable the resection of non-polypoid flat lesions larger than 2 cm. Lesions previously treated with colectomy can now be resected by ESD with en-bloc resection rates of approximately 85.7% (17). However, long-term data on the risk of local or distant recurrence after endoscopic resection in IBD is lacking. It is crucial to evaluate complete (R0) and curative resection rates, as well as the rate of local recurrence, based on the type of endoscopic treatment. In light of the 21st century advancements, characterized by high-definition endoscopes and targeted treatments, it is imperative to:

• Assess the prevalence and incidence of dysplasia in IBD and its risk of progression to CRC.
• Specifically characterize the endoscopy and histology of pre-neoplastic lesions in IBD to facilitate better selection of lesions amenable to endoscopic treatment or surgery.
• Evaluate the rates of local and distant recurrence over time, considering factors associated with this evolving risk (IBD characteristics, endoscopic appearance, histology, type of resection, etc.).

Conditions

Crohn Disease (CD); Colitis Ulcerative

Keywords

All IBD patients requiring colonoscopy for screening or treatment of dysplasia are eligible for inclusion

Outcome Measures

Primary Outcomes (1)

• To evaluate the prevalence of dysplasia in patients with IBD at high risk of preneoplastic lesions followed prospectively in a screening program at the time of high-definition endoscopes.

  The primary endpoint is the prevalence of dysplasia in IBD patients at high risk of dysplasia estimated at their first endoscopy in the study.

  "From enrollment to the end of study at 7 years"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All IBD patients requiring colonoscopy for screening or treatment of dysplasia are eligible for inclusion. All consecutive patients from selected centers meeting the inclusion criteria will be included.

You may qualify if:

• Patients age ≥ 18 years
• Documented diagnosis of CD or UC established based on standard clinical, endoscopic and histological criteria.
• IBD patients requiring screening colonoscopy for dysplasia as following:
• IBD (CD/UC) evolving for more than 8 years, or for ≥1 year if associated with Primary Sclerosing Cholangitis (PSC)
• For UC: Extended ulcerative colitis (E2 or E3 in the Montreal classification)
• For CD: Colonic (L2) or ileocolonic (L3) Crohn's disease with \> 50% involvement of the colon.
• Patient affiliated to the health security system
• Patient who has received information about the study by the investigator and agreed to participate.

You may not qualify if:

• Patient followed for ileal Crohn's disease (L1)
• Patient followed for rectal ulcerative colitis (E1)
• Patient referred for a therapeutic endoscopic procedure, without prior or subsequent follow-up in the participating center
• Patients \< 18 years old
• Patient under guardianship or curatorship
• Patient objects to their personal data being used in the context of research

Sponsors & Collaborators

• Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives: lead
• AFA Crohn /RCH: collaborator
• Société Nationale Française de Gastroentérologie: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

biopsies will undergo examination by a local expert pathologist

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

SEGUIN A Project manager

CONTACT

+ 33 (0) 7 66 42 69 85; aseguin@getaid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): September 15, 2033
• Study Completion (Estimated): September 15, 2033
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share