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

March 31, 2010
June 21, 2015
January 2010
June 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01180452 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Endoscopic Detection of Dysplasia in Crohn 's Disease Patient
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

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

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Crohn Disease Located in Jejunum or Ileum
Procedure: enteroscopy
endoscopic enteroscopy to do biopsies on jejunum
Single group open label
Prospective Cohort
Intervention: Procedure: enteroscopy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01180452
GETAID 2008-4
No
Not Provided
Not Provided
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Not Provided
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
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP