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

The Role of Peripheral and Tissue Chitinase 3-like 1 Protein (YKL 40) Levels as a Bio-marker for Gastrointestinal and Liver Disease

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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).

Exclusion Criteria:

• Pregnancy
• Inability to obtain informed consent
• Bleeding diathesis or any other condition precluding tissue biopsy.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control; Healthy controls
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chitinase 3-like-1 (YKL 40) levels measured by ELISA	ELISA will be used to determine the blood levels and biopsies (organ cultures) levels of Chitinase 3-like-1	5 years

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center
• Investigators: Principal Investigator: Eran Goldin, MD, Shaare Zedek Medical Center, Jerusalem, Israel

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 9, 2016

Study Registration Dates

• First Submitted: July 2, 2013
• First Submitted That Met QC Criteria: May 14, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 14, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: 3287-02-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No