- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03751722
Genetic an Functional Studies of Patient With Inflammatory Bowel Disease (MINOTOR)
November 21, 2018 updated by: University Hospital, Lille
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
630
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lille, France
- CHRU, Hôpital Claude Huriez
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All outpatients and inpatients from gastroenterology units of adulte and pediatric references centers
Description
Inclusion Criteria:
- patient with definite crohn's disease or ulcerative colitis
Exclusion Criteria:
- patient receiving anti-TNF therapy during 14 days before inclusion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Isolated macrophage response measured by PCR
Time Frame: Baseline: one session
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Corinne Gower-Rousseau, MD, PhD, University Hospital, Lille
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2007
Primary Completion (Actual)
April 10, 2017
Study Completion (Actual)
April 10, 2017
Study Registration Dates
First Submitted
November 20, 2018
First Submitted That Met QC Criteria
November 21, 2018
First Posted (Actual)
November 23, 2018
Study Record Updates
Last Update Posted (Actual)
November 23, 2018
Last Update Submitted That Met QC Criteria
November 21, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005/0528
- DGS 2006/0083 (Other Identifier: Number reference,Ministry of health)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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