The Role of Peripheral and Tissue Chitinase 3-like 1 Protein Levels as a Bio-marker in IBD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-01-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The digestive system may be involved in various pathologic conditions, with different inflammatory, metaplastic and neoplastic aspects. As the therapeutic tool-box for digestive diseases grows and becomes more focused, at times targeting specific molecules, decision making in managing patients becomes more and more important, and must be evidence based.

Defining biomarkers with predictive value will theoretically allow physicians in making diagnosis, deciding on a suitable first line therapy (with specific endpoints suggesting response or indicating 2nd line therapy is indicated) and finally may suggest surgical intervention is warranted, thus forming an "individually tailored treatment" for each patient. These biomarkers may be located in the peripheral blood, in the gastrointestinal tract in general, or confined to specific intestinal lesions.

Chitinase 3-like 1 protein (YKL-40) is produced by different tissues (e.g. - synovium, smooth muscle, intestinal epithelium). Its specific action is unknown, but several reports have described it in different inflammatory conditions including those involving the gastrointestinal system. Chitinase 3 like-1 protein (YKL-40) has also been studied for its possible role in angio and onco-genesis.

This study aims to evaluate the diagnostic and prognostic value of peripheral and tissue Chitinase 3-like-1 (YKL 40) levels in gastrointestinal and liver diseases.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Interactions Between Immune Cells of Intestinal Mucosa or Peripheral Blood With the Extracellular Matrix in Inflammatory Bowel Disease (IBD)

NCT00915044

Inflammatory Bowel Disease

UNKNOWN

Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases

NCT03841045

Colitis, Ulcerative Crohn Disease

UNKNOWN

Biomarker-based Multidisciplinary Team (Bio-MDT) Approach to Personalized Microbial-targeted Treatment of Pouchitis and Crohn's Disease

NCT04082559

Inflammatory Bowel Diseases

UNKNOWN NA

Construction and Validation of a Predictive Model for the Efficacy of Different Biologics in Inflammatory Bowel Disease

NCT07181525

Inflamatory Bowel Disease

RECRUITING

Immune Regulation in Ulcerative Colitis or Crohn s Disease

NCT00001184

Inflammatory Bowel Disease Ulcerative Colitis Chrohn's Disease

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

For periphery tests: 10 ml blood will be collected from all eligible subjects into SST tubes. Then serum will be separated and freeze at -80 degrees until analysis of Chitinase 3 like-1 protein by ELISA.

For tissue tests: biopsies will be taken from colons of eligible participants. One part of these biopsies will be freeze until analysis of Chitinase 3 like-1 protein by ELISA. The other part of the biopsies will be placed in dishes with appropriate media and will be incubated in 37 degrees in order to follow cytokine secretion for 24 h. Media will be collected after 24 h and then freeze until further analysis of Chitinase 3 like-1 protein by ELISA. The investigators will also measure mRNA levels of Chitinase 3 like-1 protein in collected biopsies.

The investigators will try to correlate between the Chitinase 3 like-1 protein levels in the blood and in tissue among various groups of participants and will compare between healthy participants and IBD participants. The investigators will also follow mRNA expression in tissue biopsies taken from all the participants.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammatory Bowel Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Healthy controls

No interventions assigned to this group

Study group

Patient diagnosed with any disorder of the digestive system (including the alimentary tract, hepatobiliary tree, pancreas, insulin resistance or diabetes, obesity or malnutrition)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age \>18 years
* Signed informed consent
* Any patient followed or treated by the digestive disease institute team (including ambulatory, hospitalized or undergoing procedure, endoscopy, surgery, endovascular or biopsy).