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

NCT03154905 | Completed

• 1 other identifier: 3287-02-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

The study allows the measurements of chitinase 3 like 1 proteins in blood and tissues. Upon consenting to participation in the study, each volunteer may consent to specimens' storage and additional testing. Even though the samples contain DNA, and participation may include analysis in the RNA level, direct DNA sequencing will not be performed and is not included in the additional testing permitted by the subject.

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Eran Goldin, MD

  Shaare Zedek Medical Center, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Digestive Diseases Institute

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: May 16, 2017
• Study Start: February 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: January 9, 2016
• Last Updated: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)