Endoscopic Detection of Dysplasia in Crohn 's Disease Patient (DYDJI)
This study is currently recruiting participants.
Verified August 2011 by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Sponsor:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Information provided by (Responsible Party):
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier:
NCT01180452
First received: March 31, 2010
Last updated: April 16, 2012
Last verified: August 2011
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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
| 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180452
Contacts
| Contact: Julie Démolin | 0142499597 | arc.getaid@gmail.com |
Locations
| France | |
| 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 | |
| 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 Saint Louis | Active, not recruiting |
| Paris, France, 75010 | |
| 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
Investigators
| Principal Investigator: | Marion Simon, Doctor | GETAID |
| Study Chair: | Marc Lémann, PhD | GETAID |
| Study Director: | Yoram BOUHNIK, PhD | GETAID |
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: | 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 dysplasia adenocarcinoma |
endoscopy jejunum ileum |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013