Endoscopic Detection of Dysplasia in Crohn 's Disease Patient (DYDJI)

June 21, 2015 updated by: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Endoscopic Detection of Small Bowel Dysplasia and Cancer in Patients With Jejuna or Ileal Crohn Disease : Prospective Study in a Cohort of High Risk Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens
      • Besancon, France, 25030
        • CHU Besançon
      • Clichy, France, 92110
        • Hopital Beaujon
      • Le Kremlin Bicetre, France, 94275
        • Hôpital Bicêtre
      • Lille, France, 59037
        • CHRU Lille
      • Nice, France, 06202
        • CHU Nice
      • Paris, France, 75010
        • Hopital Saint Louis
      • Paris, France, 75674
        • Institut Mutualiste Montsouris (IMM)
      • Pessac, France, 33604
        • Hopital Haut Leveque
      • Pierre Benite, France, 69495
        • CHU Lyon
      • Rouen, France, 76031
        • CHU Rouen
      • St Etienne, France, 42270
        • CHU Saint Etienne
      • Toulouse, France, 31403
        • CHU Toulouse
      • Tours, France, 37044
        • CHU Tours
      • Vandoeuvre Les Nancy, France, 54500
        • CHU Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • More than 18-years-old
  • Crohn disease on jejunum and/or ileum since at least 10 years
  • Radiography done during last year

Exclusion Criteria:

  • Dysplasia previously detected
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single group open label
Prospective Cohort
Procedure: enteroscopy
endoscopic enteroscopy to do biopsies on jejunum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of dysplasia and adenocarcinoma
Time Frame: 2 months
dysplasia will be described as high or low level Samples will be analysed by 2 different team of anapathologists
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of endoscopic detection
Time Frame: 1-3 Months
the success will be measured by reaching at least one pathologic area during the endoscopic procedure
1-3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Investigators

  • Principal Investigator: Marion Simon, Doctor, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
  • Study Chair: Marc Lémann, PhD, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
  • Study Director: Yoram BOUHNIK, PhD, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 31, 2010

First Submitted That Met QC Criteria

August 11, 2010

First Posted (Estimate)

August 12, 2010

Study Record Updates

Last Update Posted (Estimate)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 21, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETAID 2008-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn Disease Located in Jejunum or Ileum

Clinical Trials on enteroscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe