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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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Crohn Disease Located in Jejunum or Ileum

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Frequency of dysplasia and adenocarcinoma

Outcome Description:

dysplasia will be described as high or low level Samples will be analysed by 2 different team of anapathologists

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

Marion Simon, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

GETAID

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GETAID 2008-4

NCT ID:

NCT01180452

Start Date:

January 2010

Completion Date:

December 2012

Related Keywords:

  • Crohn Disease Located in Jejunum or Ileum
  • Crohn disease
  • dysplasia
  • adenocarcinoma
  • endoscopy
  • jejunum
  • ileum
  • Crohn Disease

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