NCT03751722

Brief Summary

The objective of this study is to study the response of macrophages, isolated from patients with ulcerative colitis (Crohn's disease) or Crohn's disease (CD), to 6 candidate enterogenous and their derivatives, depending on the genotype for associated polymorphisms. to the development of IBD

Trial Health

87
On Track

Trial Health Score

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

Enrollment
630

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

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

Study Start

First participant enrolled

February 1, 2007

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

10.2 years

First QC Date

November 20, 2018

Last Update Submit

November 21, 2018

Conditions

Inflammatory Bowel Diseases

Keywords

Crohn diseaseUlcerative colitisgenetic makerscytokines

Outcome Measures

Primary Outcomes (1)

  • Isolated macrophage response measured by PCR

    identification of macrophage activation markers specific analysis of gene expression (by PCR in real time) and / or the production (ELISA) of proinflammatory molecules (IL-6, TNF-1 and IL-8), anti-inflammatory (IL-10) and immunomodulatory (IL4,PPAR -2, MOR)

    Baseline: one session

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All outpatients and inpatients from gastroenterology units of adulte and pediatric references centers

You may qualify if:

  • patient with definite crohn's disease or ulcerative colitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU, Hôpital Claude Huriez

Lille, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Corinne Gower-Rousseau, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2018

First Posted

November 23, 2018

Study Start

February 1, 2007

Primary Completion

April 10, 2017

Study Completion

April 10, 2017

Last Updated

November 23, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)