The Connection Between Liver Disease and Chitinase Proteins
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00852293|
Recruitment Status : Unknown
Verified February 2009 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : February 26, 2009
Last Update Posted : February 26, 2009
Chitinase and chitinase like proteins are members of the 18-glycosyl-hydrolase family. Several reports have linked the chitinase 3 like 1 protein with colitis, asthma and liver disease.
This study aims to evaluate the correlation of chitinase 3 like 1 protein with clinical parameters such as disease severity, reaction to treatment, portal hypertension and prognosis.
|Condition or disease||Intervention/treatment|
|Liver Disease||Other: A blood test|
Chitin is a poly saccharide, abundant in insects, fungi, crustaceans and other organisms, but not in mammals. Chitinases and chitinase like proteins (which have the ability to bind chitin without enzymatic activity) are members of the 18-glycosyl-hydrolase family. Their function and importance are still not clearly understood. However, several reports have linked the chitinase 3 like 1 protein with colitis and asthma. Furthermore, Johansen et al have reported elevated levels of chitinase 3 like 1 protein in patients with liver disease, mainly those with alcoholic liver disease (ALD) and fibrosis. This report consisted of 51 patients with ALD ,but only 16 and 17 patients with fatty liver and viral hepatitis respectively.
This study aims to evaluate the correlation of chitinase 3 like 1 protein with clinical parameters such as disease severity, reaction to treatment, portal hypertension (when measured) and prognosis.
a. Subjects i.The study will include patients with liver disease followed at the liver unit, Hadassah Medical Center, Jerusalem. b. Planned number i.The study is planned to include 200 volunteers. c. Inclusion criteria i.Patients with liver disease followed at the liver unit at Hadassah Medical Center. ii.Patients who have given their informed consent for participation in the study. d. Exclusion criteria i.Age<18y. ii.Pregnancy iii.Patients with other conditions associated with elevated chitinase 3 like 1 protein (such as asthma and rheumatoid arthritis). e. Chitinase 3 like-1 protein levels will be measured by a commercially available kit (Human Chitinase 3-like 1 Quantikine ELISA Kit, catalogue number - DC3L1, Biotest LTD). f. Stopping/modifying criteria i.At subjects' request. g. Trial entry and enrollment i.A consecutive cohort will be recruited form amongst the patients followed at the liver unit in Hadassah medical center. Jerusalem Israel. ii.Consenting patients will have a blood test drawn for chitinase 3 like 1 protein levels. iii.Clinical details of each patient will be obtained form the liver unit. iv.In addition to the routine follow up at the liver unit, follow up will be performed at 1,2 and 5 years. h. Statistical considerations i.Subjects will be grouped according to their clinical properties (disease, treatment, severity, portal hypertension) ii.Chitinase 3 like 1 protein levels will be compared between each group. F. Informed consent i.Each subject will be enrolled and enter the study only after giving an informed consent. G. Adherence to study eligibility i.The study will be conducted in accordance with good clinical practice (GCP) guidelines, and the study protocol. H. Safeguarding of documents i.The privacy of the subjects and all confidentiality issues will be handled in accordance with applicable law and guidelines of the institution and the Helsinki Committee, the Israeli ministry of health, or the other appropriate regulatory authorities.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||The Connection Between Liver Disease and Chitinase Proteins|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||March 2010|
|Estimated Study Completion Date :||March 2014|
Patients with liver disease followed at the liver unit at Hadassah Medical Center.
Other: A blood test
A blood test of about 5ml of blood will be taken to determine Chitinase 3 like-1 protein levels.
- Comparison between Chitinase 3 like-1 protein levels and liver disease parameters including disease severity, portal hypertension, reaction to treatment and prognosis. [ Time Frame: 5 years ]
Biospecimen Retention: Samples Without DNA
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): NCT00852293
|Contact: Arik Tzukert, DMD||00 972 2 firstname.lastname@example.org|
|Contact: Hadas Lemberg, PhD||00 972 2 email@example.com|
|Hadassah Medical Organization,||Not yet recruiting|
|Contact: Arik Tzukert, DMD : 00 972 2 6776095 firstname.lastname@example.org|
|Contact: Hadas Lemberg, PhD 00 972 2 6777572 email@example.com|
|Principal Investigator: Tomer Adar, MD|
|Sub-Investigator: Meir Mizrahi, MD|
|Sub-Investigator: Horowitz Yuval, MD|