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Not yet recruitingNCT07719426IB DYSPLASIAUpdated Jul 22, 2026

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

An observational study in Crohn Disease (CD) and Colitis Ulcerative, sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years and older
Sex
All
01

Study 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.).
02

Conditions studied

  • Crohn Disease (CD)
  • Colitis Ulcerative

Keywords

  • All IBD patients requiring colonoscopy for screening or treatment of dysplasia are eligible for inclusion
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples without dna
05

What researchers measure

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.

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07719426
Lead sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Collaborators
AFA Crohn /RCH, Société Nationale Française de Gastroentérologie
Responsible party
Sponsor
First posted
Jul 22, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Sep 15, 2033 (estimated)
Completion
Sep 15, 2033 (estimated)
Last update
Jul 22, 2026

Study contacts

SEGUIN A Project manager
Contact
aseguin@getaid.org
+ 33 (0) 7 66 42 69 85

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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