NCT00780949

Brief Summary

The project is based on adult and paediatric cohorts among the largest ones in Paris and located at Saint Louis and Robert Debré hospitals. Experiments will be performed at INSERM Unit U843 in collaboration with the department of immunology and statistics, Robert Debré Hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

August 3, 2012

Status Verified

July 1, 2012

Enrollment Period

3 years

First QC Date

October 27, 2008

Last Update Submit

August 2, 2012

Conditions

Crohn's Disease

Keywords

Crohn's Disease, inflammatory bowel disease, Peyer's patches

Outcome Measures

Primary Outcomes (1)

  • cytokine production and cell phenotype in Peyer patches

    final time frame at the end of the study

Study Arms (1)

1: Crohn's disease patient

EXPERIMENTAL

intestinal biopsies

Other: intestinal biopsies

Interventions

intestinal biopsiesOTHER

intestinal biopsies during routine endoscopy

Also known as: intestinal biopsies during routine endoscopy
1: Crohn's disease patient

Eligibility Criteria

Age5 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Children and adults ≥ 5 ans and ≤ 65 ans with a programmed routine colonoscopy for Crohn's disease, ulcerative colitis, or another benign gastroenterological disorder

You may not qualify if:

  • Patients \< 5 ans or \> 65 ans
  • Patients with contra-indications for multiple biopsies
  • Patients with an undeterminate colitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Robert Debre

Paris, 75019, France

Location

MeSH Terms

Conditions

Crohn DiseaseInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Jean-Pierre HUGOT, Professeur

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2008

First Posted

October 28, 2008

Study Start

January 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

August 3, 2012

Record last verified: 2012-07

Locations

FR(1)