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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier:
First received: March 31, 2010
Last updated: April 16, 2012
Last verified: August 2011

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

Estimated Enrollment: 50
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: enteroscopy
    endoscopic enteroscopy to do biopsies on jejunum

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

Contact: Julie Démolin 0142499597 arc.getaid@gmail.com

Chu Amiens Active, not recruiting
Amiens, France, 80054
Chu Besancon Recruiting
Besancon, France, 25030
Contact: Maria NACHURY, MD    +33 3 81 66 82 54    mnachury@chu-besancon.fr   
Principal Investigator: Maria NACHURY, MD         
Hopital Beaujon Active, not recruiting
Clichy, France, 92110
Hopital Bicetre Active, not recruiting
Le Kremlin Bicetre, France, 94275
Chru Lille Recruiting
Lille, France, 59037
Contact: Jean-Frédéric COLOMBEL, MD,PhD    +33 3 20 44 47 14    jean-frederic-colombel@chru-lille.fr   
Contact: Géraldine MEULIN    +33 3 20 44 56 20    g-meulin@chru-lille.fr   
Principal Investigator: Jean-Frédéric COLOMBEL, MD,PhD         
Sub-Investigator: Gwenola VERNIER-MASSOUILLE, MD         
Sub-Investigator: Vincent MAUNOURY, MD         
CHU NICE Recruiting
Nice, France, 06202
Contact: Xavier HEBUTERNE, MD,PhD    +33492066168    hebuterne.x@chu-nice.fr   
Principal Investigator: Xavier HEBUTERNE, MD,PhD         
Sub-Investigator: Jérome FILIPPI, MD         
Hopital Saint Louis Active, not recruiting
Paris, France, 75010
Institut Mutualiste Montsouris (Imm) Recruiting
Paris, France, 75674
Contact: Antoine BLAIN, MD    +33156616316    antoine.blain@imm.fr   
Sub-Investigator: Antoine BLAIN, MD         
Principal Investigator: Marion SIMON, MD         
Hopital Haut Leveque Recruiting
Pessac, France, 33604
Contact: David LAHARIE, MD    +33 5 57 65 64 38    david.laharie@chu-bordeaux.fr   
Contact: Sylvie RAZAIRE    +33 5 57 65 63 11      
Principal Investigator: David LAHARIE, MD         
CHU LYON Not yet recruiting
Pierre Benite, France, 69495
Contact: Bernard FLOURIE, MD,PhD    +33478861288    bernard.flourie@chu-lyon.fr   
Principal Investigator: Bernard FLOURIE, MD,PhD         
Sub-Investigator: Stéphane NANCEY, PhD         
Chu Rouen Recruiting
Rouen, France, 76031
Contact: Eric LEREBOURS, MD,PhD    +33232888101    eric.lerebours@chu-rouen.fr   
Contact: Julien BLOT       julien.blot@chu-rouen.fr   
Sub-Investigator: Eric LEREBOURS, MD,PhD         
Principal Investigator: Guillaume SAVOYE, PhD         
Chu Saint Etienne Active, not recruiting
St Etienne, France, 42270
Chu Toulouse Active, not recruiting
Toulouse, France, 31403
Chu Tours Active, not recruiting
Tours, France, 37044
Chu Nancy Recruiting
Vandoeuvre Les Nancy, France, 54500
Contact: Florence SALAUN    +33321504574    arcgastro.fsalaun@gmail.com   
Sub-Investigator: Marc-André BIGARD, MD,PhD         
Principal Investigator: Laurent PEYRIN-BIROULET, MD,PhD         
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
Study First Received: March 31, 2010
Last Updated: April 16, 2012
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

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

ClinicalTrials.gov processed this record on May 29, 2015