Crohn Disease (CD)IB DYSPLASIANCT07719426
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 of Crohn Disease (CD) and Colitis Ulcerative, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease (CD), Colitis Ulcerative
- How many people
- 800 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Sep 2026to 17 Sep 2033
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU d'Amiens
Amiens
- Recruiting
CHU de Besançon
Besançon
About this study
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.
Read more
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.).
- Conditions
- Crohn Disease (CD), Colitis Ulcerative
- Keywords
- All IBD patients requiring colonoscopy for screening or treatment of dysplasia are eligible for inclusion
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "From enrollment to the end of study at 7 years"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start17 Sep 2026
- Primary completion17 Sep 2033 (estimated)
- Study completion17 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Collaborators
- AFA Crohn /RCH, Société Nationale Française de Gastroentérologie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719426
- Sponsor's protocol ID
- 2025-A02237-42
- Acronym
- IB DYSPLASIA
- Status last verified
- Nov 2026
- First submitted
- 17 Jul 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- IB DYSPLASIA / 2025-A02237-42
- Conditions
- Crohn Disease (CD), Colitis Ulcerative
- Keywords
- All IBD patients requiring colonoscopy for screening or treatment of dysplasia are eligible for inclusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Collaborators
- AFA Crohn /RCH, Société Nationale Française de Gastroentérologie
- Study start
- 17 Sep 2026 (actual)
- Primary completion
- 17 Sep 2033 (estimated)
- Study completion
- 17 Sep 2033 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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:
- Patient affiliated to the health security system
- Patient who has received information about the study by the investigator and agreed to participate.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: "From enrollment to the end of study at 7 years"
The primary endpoint is the prevalence of dysplasia in IBD patients at high risk of dysplasia estimated at their first endoscopy in the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease (CD) and Colitis Ulcerative, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SEGUIN A Project manager (+ 33 (0) 7 66 42 69 85, aseguin@getaid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: "From enrollment to the end of study at 7 years"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.