Lipid Mediators in Colonic Biopsies as Biomarkers of Disease Activity of Inflammatory Bowel Diseases
MICILIP
Quantitative Analysis of Lipid Mediators in Colonic Biopsies From Patients With Inflammatory Bowel Diseases and From Control Patients.
2 other identifiers
interventional
124
1 country
1
Brief Summary
We will quantify one of the lipid compounds (5,6 epoxy eicosatrienoic acid (5,6 EET), 5,6- EpoxyEicosaTrienoic acid) in colonic biopsies of Inflammatory Bowel Disease patients. We will evaluate its possible use as a pathological activity biomarker and its potential as a therapeutic target. We hypothesized that 5,6-EET is present in human colonic tissues in varying quantities depending on the pathological state of the IBD patient.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 15, 2013
CompletedFirst Posted
Study publicly available on registry
November 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedFebruary 23, 2017
February 1, 2017
2.2 years
November 15, 2013
February 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure of 5,6-EET quantity in a colonic biopsy
Mass spectrography analysis of the biopsies will be performed each time at least 10 samples are available
5 minutes
Secondary Outcomes (1)
Nature and quantity of Lipid metabolites as a function of the patient clinical profile (mapping)
5 minutes
Study Arms (2)
IBD patients
OTHERPatients (diagnosed with IBD) having a screening colonic biopsy
Control Group
OTHERindividuals undergoing screening colonic biopsy for colon cancer or polyp detection, who have not been diagnosed with any intestinal pathology.
Interventions
Colonoscopy or coloscopy can provide a visual diagnosis and grants the opportunity for biopsy or removal of suspected colorectal cancer lesions. The endoscope is then passed through the anus up the rectum, the colon, and ultimately the terminal ileum. The endoscope has a movable tip and multiple channels for instrumentation, air, suction and light. Biopsies are frequently taken for histology, needed for cancer or IBD diagnosis. Extra-biopsies for research purpose will only be performed if the clinician decides that they are necessary for the clinical diagnosis or for the disease follow-up. For this protocol, collecting these extra biopsies should last under 5 minutes and should not extend the procedure by more than this time.
Eligibility Criteria
You may qualify if:
- Major/18 years and older
- Covered by a health insurance plan
- Patient having a screening colonoscopy for/with a suspicion of IBD or, IBD Patient, either in acute phase or in remission, having a therapeutic colonoscopy as part of his/her regular follow- up/usual care
- Must be able to understand and voluntarily sign an informed consent prior to any study procedures
- Major/18 years and older Covered by a health insurance plan
- Patients having a screening colonoscopy for polyp or cancer detection or patient undergoing a colic resection
- Must be able to understand and voluntarily sign an informed consent prior to any study procedures
You may not qualify if:
- Unable to comprehend the full nature and purpose of the study, and/or difficulty in communicating with the investigator
- Deprivation of liberty by administrative or legal decision
- Any other pathological or psychological condition considered by the investigator as interfering with the study (pregnancy, breastfeeding, cancer detection, AIDS, celiac disease)
- Presence of cancerous lesions
- Anatomopathological results excluding the possibility of an IBD
- Contra-indications to carrying out a lower digestive endoscopy
- Unable to comprehend the full nature and purpose of the study,
- and/or difficulty in communicating with the investigator
- Deprivation of liberty by administrative or legal decision
- Contra-indications to carrying out a lower digestive endoscopy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Toulouse
Toulouse, 31059, France
Related Publications (1)
Rahabi M, Jacquemin G, Prat M, Meunier E, AlaEddine M, Bertrand B, Lefevre L, Benmoussa K, Batigne P, Aubouy A, Auwerx J, Kirzin S, Bonnet D, Danjoux M, Pipy B, Alric L, Authier H, Coste A. Divergent Roles for Macrophage C-type Lectin Receptors, Dectin-1 and Mannose Receptors, in the Intestinal Inflammatory Response. Cell Rep. 2020 Mar 31;30(13):4386-4398.e5. doi: 10.1016/j.celrep.2020.03.018.
PMID: 32234475DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent Alric, MD PhD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2013
First Posted
November 21, 2013
Study Start
February 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
February 23, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share