DYDJI: Endoscopic Detection of Dysplasia in Crohn 's Disease Patient

Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives (Other)

Overall Status

Completed

CT.gov ID

NCT01180452

Collaborator

(none)

107

Enrollment

Locations

Arm

Duration (Months)

7.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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

Actual Enrollment :

107 participants

Allocation:

N/A

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 :

Jan 1, 2010

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Single group open label

Prospective Cohort

Procedure: enteroscopy

endoscopic enteroscopy to do biopsies on jejunum

Outcome Measures

Primary Outcome Measures

Frequency of dysplasia and adenocarcinoma [2 months]
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 [1-3 Months]
the success will be measured by reaching at least one pathologic area during the endoscopic procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Chu Amiens	Amiens	France	80054
2	Chu Besancon	Besancon	France	25030
3	Hopital Beaujon	Clichy	France	92110
4	Hopital Bicetre	Le Kremlin Bicetre	France	94275
5	Chru Lille	Lille	France	59037
6	CHU NICE	Nice	France	06202
7	Hopital Saint Louis	Paris	France	75010
8	Institut Mutualiste Montsouris (Imm)	Paris	France	75674
9	Hopital Haut Leveque	Pessac	France	33604
10	CHU LYON	Pierre Benite	France	69495
11	Chu Rouen	Rouen	France	76031
12	Chu Saint Etienne	St Etienne	France	42270
13	Chu Toulouse	Toulouse	France	31403
14	Chu Tours	Tours	France	37044
15	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