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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2014 by ido laish, Meir Medical Center.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
ido laish, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT02247622
First received: July 10, 2013
Last updated: September 19, 2014
Last verified: September 2014
  Purpose
PSC is a chronic cholestatic disorder. The investigators intend to study some telomere parameters and telomere length in order to predict a premalignant state.

Condition
Primary Sclerosing Cholangitis Inflammatory Bowel Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Primary Sclerosing Cholangitis Telomere Length

Resource links provided by NLM:


Further study details as provided by ido laish, Meir Medical Center:

Primary Outcome Measures:
  • Telomere length [ Time Frame: 1.5 years ]

Secondary Outcome Measures:
  • number of cells with increased telomerase RNA component (TERC) expression [ Time Frame: 1.5 years ]

Estimated Enrollment: 60
Study Start Date: February 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy control
IBD
patients with inflammatory bowel disease, study group
PSC
patients with primary sclerosing cholangitis, study group

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with primary sclerosing cholangitis and inflammatory bowel disease
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02247622

Contacts
Contact: Ido Laish, MD +972-549477261 ido.laish@gmail.com

Locations
Israel
Meir Medical Center Recruiting
Kfar Saba, Israel
Contact: Ido Laish, MD       ido.laish@gmail.com   
Principal Investigator: Ido Laish, Md         
Sponsors and Collaborators
Meir Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ido laish, Md., Meir Medical Center
ClinicalTrials.gov Identifier: NCT02247622     History of Changes
Other Study ID Numbers: 1.1
Study First Received: July 10, 2013
Last Updated: September 19, 2014

Keywords provided by ido laish, Meir Medical Center:
telomeres
PSC

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Cholangitis
Cholangitis, Sclerosing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Bile Duct Diseases
Biliary Tract Diseases

ClinicalTrials.gov processed this record on June 27, 2017