Lipid Mediators in Colonic Biopsies as Biomarkers of Disease Activity of Inflammatory Bowel Diseases

NCT ID: NCT01990716

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-05-31

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.

Detailed Description

The project is an exploratory physiopathological/translational pilot study, aiming at understanding the relative importance of the lipid compounds, especially 5,6-EET, in Inflammatory Bowel Diseases.

Using mass spectrometry, 5,6-EET and other 33 lipid metabolites will be quantified in situ in colonic biopsies from IBD patients and from control patients. We will compare quantities of 5,6-EET in inflammatory and non-inflammatory zones of biopsies from IBD patient to biopsies from control patient. We will establish a cluster of lipid compounds associated with pathological activity. We will determine the exposed profile of receptor lipid mediators expressing to the 5,6-EET lipid compound and one of its signalization.

All data will be submit to statistical analysis to confirm relevance.

We expect this pilot study to help us define 5,6-EET and other components of the same metabolic family as markers for IBD activity. It could point lipid mediators and their receptors as potential new therapeutic targets.

It will increase our knowledge on current treatment efficiency by evidencing lipid markers for the inflammatory condition.

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

IBD patients

Patients (diagnosed with IBD) having a screening colonic biopsy

Group Type: OTHER

Colonic Biopsy

Intervention Type: OTHER

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.

Control Group

individuals undergoing screening colonic biopsy for colon cancer or polyp detection, who have not been diagnosed with any intestinal pathology.

Group Type: OTHER

Colonic Biopsy

Intervention Type: OTHER

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.

Interventions

Colonic Biopsy

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• Participation in another biomedical research/clinical trial with experimental medication within the last 3 months prior to the selection visit or patients still within a biomedical research exclusion period
• 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
• Participation in another biomedical research/clinical trial with experimental medication within the last 3 months prior to the selection visit or patients still within a biomedical research exclusion period
• Contra-indications to carrying out a lower digestive endoscopy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent Alric, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital Toulouse

Toulouse, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 32234475 (View on PubMed)

Other Identifiers

AOL 2012

Identifier Type: OTHER

Identifier Source: secondary_id

12 393 02

Identifier Type: -

Identifier Source: org_study_id