Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Observational · No treatment assigned · Sites not listed yet · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease (CD) and Colitis Ulcerative. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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:
Plus 5 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 800 participants are expected to take part.
- Start date: 2026-09-15 (planned).
- Main results expected around 2033-09-15 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- 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. ("From enrollment to the end of study at 7 years")
In the researchers’ words
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).
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease (CD); Colitis Ulcerative |
| Lead sponsor | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
| Collaborators | AFA Crohn /RCH; Société Nationale Française de Gastroentérologie |
| Enrollment | 800 (estimated) |
| Start date | 2026-09-15 |
| Primary completion (est.) | 2033-09-15 |
| First posted | 2026-07-22 |
| Last updated | 2026-07-22 |
| Official title | Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study |
| ClinicalTrials.gov ID | NCT07719426 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.