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Trial record 15 of 415 for:    shaare zedek

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

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ClinicalTrials.gov Identifier: NCT03154905
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Eran Goldin, Shaare Zedek Medical Center

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.


Condition or disease
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.


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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Peripheral and Tissue Chitinase 3-like 1 Protein (YKL 40) Levels as a Bio-marker for Gastrointestinal and Liver Disease
Study Start Date : February 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 9, 2016

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)



Primary Outcome Measures :
  1. Chitinase 3-like-1 (YKL 40) levels measured by ELISA [ Time Frame: 5 years ]
    ELISA will be used to determine the blood levels and biopsies (organ cultures) levels of Chitinase 3-like-1


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154905


Locations
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Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Principal Investigator: Eran Goldin, MD Shaare Zedek Medical Center, Jerusalem, Israel

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Responsible Party: Prof. Eran Goldin, Chairman, Digestive Diseases Institute, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT03154905     History of Changes
Other Study ID Numbers: 3287-02-01
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases