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

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.).

Study Overview

• Status: Not yet recruiting
• Conditions: Colitis Ulcerative; Crohn Disease (CD)

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: SEGUIN A Project manager; Phone Number: + 33 (0) 7 66 42 69 85; Email: aseguin@getaid.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): September 15, 2033
• Study Completion (Estimated): September 15, 2033

Study Registration Dates

• First Submitted: July 17, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: All IBD patients requiring colonoscopy for screening or treatment of dysplasia are eligible for inclusion
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Crohn Disease
• Other Study ID Numbers: 2025-A02237-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No