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Endoscopic Detection of Dysplasia in Crohn 's Disease Patient

NCT01180452 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2015-06-23

No results posted yet for this study

Summary

Patients with Crohn's disease (CD) have an increased risk of small bowel adenocarcinoma (SBA). Long duration of CD is the main risk factor. SB dysplasia has been associated with SBA in 20% of cases, always described in diseased sites. The progression to neoplasia and natural history remains unknown but progression of inflammation to dysplasia and then to adenocarcinoma is suspected.

As for surveillance recommendations for colorectal carcinoma in long standing inflammatory colonic disease, endoscopic screening of SB could be proposed in CD patients with risk factors of SBA. No study can be found in literature.

The investigators propose a multicenter exploratory open study on prospective cohort of CD patients with high risk of dysplasia or cancer. The goal is evaluate the rate of dysplasia and adenocarcinoma detected by enteroscopy with biopsies in a high risk CD population

Conditions

  • Crohn Disease Located in Jejunum or Ileum

Interventions

PROCEDURE

enteroscopy

endoscopic enteroscopy to do biopsies on jejunum

Sponsors & Collaborators

  • Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    lead OTHER

Principal Investigators

  • Marion Simon, Doctor · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

  • Marc Lémann, PhD · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

  • Yoram BOUHNIK, PhD · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01180452 on ClinicalTrials.gov