Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study (IB DYSPLASIA)
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.).
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: SEGUIN A Project manager
- Numéro de téléphone: + 33 (0) 7 66 42 69 85
- E-mail: aseguin@getaid.org
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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.
Délai: "From enrollment to the end of study at 7 years"
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The primary endpoint is the prevalence of dysplasia in IBD patients at high risk of dysplasia estimated at their first endoscopy in the study.
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"From enrollment to the end of study at 7 years"
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025-A02237-42
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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