IB DYSPLASIANCT07719426

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

StatusRecruiting

PhaseNot specified

SponsorGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Primary completionSep 17, 2033 (estimated)

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 5, 2026 Recruitment opened Show 5 more changesShow less
- Eligibility criteria expanded, about 14 words
- Study sites: 0 to 2
- Primary and study completion dates: Sep 15, 2033 to Sep 17, 2033
- Start date changed from estimate of Sep 15, 2026 to Sep 17, 2026
- Collaborators: details revised at 1 of 2 entries
Jul 17, 2026 Study First Submitted

Notable: the plan changed

Endpoints

Primary

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.

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

Sites

2 sites in 1 country

About this trial

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.).

Trial details

Enrollment: 800 participants (estimated)
Started: Sep 17, 2026
Study completion: Sep 17, 2033 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Observational
Oversight: No data monitoring committee
Conditions: Colitis, Ulcerative, Crohn Disease, Crohn Disease (CD)
Collaborators: AFA Crohn /RCH, Société Nationale Française de Gastroentérologie
First posted: Jul 22, 2026
Registry updated: Nov 6, 2026
Last verified: Nov 2026

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