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NCT02247622 Clinical Trial

Telomere Length and Other Parameters of Telomere Dysfunction in PSC and Colitis

Inflammatory Bowel Disease Clinical Trial

Official title:
Primary Sclerosing Cholangitis Telomere Length

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02247622
Other study ID # 1.1
Secondary ID
Status Recruiting
Phase N/A
First received July 10, 2013
Last updated September 19, 2014
Start date February 2012
Est. completion date September 2014

Study information
Verified date September 2014
Source Meir Medical Center
Contact Ido Laish, MD
Phone +972-549477261
Email ido.laish@gmail.com
Is FDA regulated No
Health authority Israel: The Israel National Institute for Health Policy Research and Health Services Research
Study type Observational

Clinical Trial Summary

PSC is a chronic cholestatic disorder. The investigators intend to study some telomere parameters and telomere length in order to predict a premalignant state.

Description:

Primary sclerosing cholangitis (PSC) and colitis are chronic inflammatory disorders with malignant potential. Telomerase is an enzyme complex that lengthens telomeres and has enhanced expression in numerous malignancies. In this study, we evaluated the telomerase gene copy number, telomere length, cells in senescence, aneuploidy and additional parameters of telomere dysfunction from peripheral blood lymphocytes of patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- informed consent

- documented PSC and inflammatory bowel disease

Exclusion Criteria:

- under 18 years, above 80 y

- known active malignancy

- decompensated cirrhosis

- patients who cannot sign informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Meir Medical Center Kfar Saba

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Telomere length 1.5 years No
Secondary number of cells with increased telomerase RNA component (TERC) expression 1.5 years No
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