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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier:
NCT01180452
First received: March 31, 2010
Last updated: June 21, 2015
Last verified: June 2015
  Purpose

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 Intervention Phase
Crohn Disease Located in Jejunum or Ileum
Procedure: enteroscopy
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:

Primary Outcome Measures:
  • Frequency of dysplasia and adenocarcinoma [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    dysplasia will be described as high or low level Samples will be analysed by 2 different team of anapathologists


Secondary Outcome Measures:
  • Success of endoscopic detection [ Time Frame: 1-3 Months ] [ Designated as safety issue: No ]
    the success will be measured by reaching at least one pathologic area during the endoscopic procedure


Enrollment: 107
Study Start Date: January 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single group open label
Prospective Cohort
Procedure: enteroscopy
endoscopic enteroscopy to do biopsies on jejunum

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180452

Locations
France
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
CHU NICE
Nice, France, 06202
Hopital Saint Louis
Paris, France, 75010
Institut Mutualiste Montsouris (Imm)
Paris, France, 75674
Hopital Haut Leveque
Pessac, France, 33604
CHU LYON
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
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
  More Information

Additional Information:
Publications:

Responsible Party: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier: NCT01180452     History of Changes
Other Study ID Numbers: GETAID 2008-4
Study First Received: March 31, 2010
Last Updated: June 21, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:
Crohn disease
dysplasia
adenocarcinoma
endoscopy
jejunum
ileum

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

ClinicalTrials.gov processed this record on July 29, 2015