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

Primary Purpose

Crohn Disease Located in Jejunum or Ileum

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
enteroscopy
Sponsored by
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Crohn Disease Located in Jejunum or Ileum focused on measuring Crohn disease, dysplasia, adenocarcinoma, endoscopy, jejunum, ileum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chu Amiens
  • Chu Besancon
  • Hopital Beaujon
  • Hopital Bicetre
  • Chru Lille
  • CHU NICE
  • Hopital Saint Louis
  • Institut Mutualiste Montsouris (Imm)
  • Hopital Haut Leveque
  • CHU LYON
  • Chu Rouen
  • Chu Saint Etienne
  • Chu Toulouse
  • Chu Tours
  • Chu Nancy

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single group open label

Arm Description

Prospective Cohort

Outcomes

Primary Outcome Measures

Frequency of dysplasia and adenocarcinoma
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
the success will be measured by reaching at least one pathologic area during the endoscopic procedure

Full Information

First Posted
March 31, 2010
Last Updated
June 21, 2015
Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
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1. Study Identification

Unique Protocol Identification Number
NCT01180452
Brief Title
Endoscopic Detection of Dysplasia in Crohn 's Disease Patient
Acronym
DYDJI
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 Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease Located in Jejunum or Ileum
Keywords
Crohn disease, dysplasia, adenocarcinoma, endoscopy, jejunum, ileum

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single group open label
Arm Type
Other
Arm Description
Prospective Cohort
Intervention Type
Procedure
Intervention Name(s)
enteroscopy
Intervention Description
endoscopic enteroscopy to do biopsies on jejunum
Primary Outcome Measure Information:
Title
Frequency of dysplasia and adenocarcinoma
Description
dysplasia will be described as high or low level Samples will be analysed by 2 different team of anapathologists
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Success of endoscopic detection
Description
the success will be measured by reaching at least one pathologic area during the endoscopic procedure
Time Frame
1-3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion Simon, Doctor
Organizational Affiliation
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc Lémann, PhD
Organizational Affiliation
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yoram BOUHNIK, PhD
Organizational Affiliation
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official's Role
Study Director
Facility Information:
Facility Name
Chu Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Chu Besancon
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Hopital Bicetre
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Chru Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU NICE
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Institut Mutualiste Montsouris (Imm)
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU LYON
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Chu Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Chu Saint Etienne
City
St Etienne
ZIP/Postal Code
42270
Country
France
Facility Name
Chu Toulouse
City
Toulouse
ZIP/Postal Code
31403
Country
France
Facility Name
Chu Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Chu Nancy
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Links:
URL
http://www.getaid.org
Description
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Endoscopic Detection of Dysplasia in Crohn 's Disease Patient

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