跳至主要内容
临床试验/NCT03154905
NCT03154905已完成不适用

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

Shaare Zedek Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Chitinase 3-like-1 (YKL 40) levels measured by ELISA

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

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

结局指标

主要结局

Chitinase 3-like-1 (YKL 40) levels measured by ELISA

时间窗: 5 years

ELISA will be used to determine the blood levels and biopsies (organ cultures) levels of Chitinase 3-like-1

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Eran Goldin

Chairman, Digestive Diseases Institute

Shaare Zedek Medical Center

研究点 (1)

Loading locations...

相似试验