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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01180452
Recruitment Status : Completed
First Posted : August 12, 2010
Last Update Posted : June 23, 2015
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Crohn Disease Located in Jejunum or Ileum Procedure: enteroscopy Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : January 2010
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Single group open label
Prospective Cohort
Procedure: enteroscopy
endoscopic enteroscopy to do biopsies on jejunum

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180452

Chu Amiens
Amiens, France, 80054
Chu Besancon
Besancon, France, 25030
Hopital Beaujon
Clichy, France, 92110
Hopital Bicetre
Le Kremlin Bicetre, France, 94275
Chru Lille
Lille, France, 59037
Nice, France, 06202
Hopital Saint Louis
Paris, France, 75010
Institut Mutualiste Montsouris (Imm)
Paris, France, 75674
Hopital Haut Leveque
Pessac, France, 33604
Pierre Benite, France, 69495
Chu Rouen
Rouen, France, 76031
Chu Saint Etienne
St Etienne, France, 42270
Chu Toulouse
Toulouse, France, 31403
Chu Tours
Tours, France, 37044
Chu Nancy
Vandoeuvre Les Nancy, France, 54500
Sponsors and Collaborators
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
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
More Information

Additional Information:

Responsible Party: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier: NCT01180452     History of Changes
Other Study ID Numbers: GETAID 2008-4
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:
Crohn disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases