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RecruitingNCT07719426IB DYSPLASIAUpdated Nov 6, 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. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

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

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Nov 6, 2026Now RecruitingFirst site in France+4 moreGo to Updates ↓
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

In context

Crohn Disease

1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.

This study's planned enrollment of 800 is above the median of 185 across 645 observational studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives is the lead sponsor of 35 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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
06

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"

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Sep 2033, 84 months after the start.

Of 231 non-industry observational studies under Crohn Disease, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 101. This study's planned 84 months is above that.

Counting every sponsor, half of 304 studies reached it within 42 months; a quarter within 29 and three quarters within 88.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2026
First posted
Jul 22, 2026
StartActual
Sep 17, 2026
Primary completionEst.
Sep 17, 2033
CompletionEst.
Sep 17, 2033
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Nov 6, 2026
Sites
2 sites added — first site in France
Show 2 added (2 France)
  • CHU d'Amiens · Amiens, France
  • CHU de Besançon · Besançon, France
Nov 6, 2026
Start date
Sep 15, 2026→Sep 17, 2026 (actual)
Nov 6, 2026
Primary completion
Sep 15, 2033→Sep 17, 2033
Nov 6, 2026
Study completion
Sep 15, 2033→Sep 17, 2033
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Not yet recruiting→Recruiting
    2 sites added — first site in France
    Show 2 added (2 France)
    • CHU d'Amiens · Amiens, France
    • CHU de Besançon · Besançon, France
    Start date Sep 15, 2026→Sep 17, 2026 (now actual)
    Primary completion Sep 15, 2033→Sep 17, 2033
    Study completion Sep 15, 2033→Sep 17, 2033
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

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 17, 2026
Primary completion
Sep 17, 2033 (estimated)
Completion
Sep 17, 2033 (estimated)
Last update
Nov 6, 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 ↗

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