NCT02247622

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

2.6 years

First QC Date

July 10, 2013

Last Update Submit

September 19, 2014

Conditions

Primary Sclerosing CholangitisInflammatory Bowel Disease

Keywords

telomeresPSC

Outcome Measures

Primary Outcomes (1)

  • Telomere length

    1.5 years

Secondary Outcomes (1)

  • number of cells with increased telomerase RNA component (TERC) expression

    1.5 years

Study Arms (3)

Healthy control

IBD

patients with inflammatory bowel disease, study group

PSC

patients with primary sclerosing cholangitis, study group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with primary sclerosing cholangitis and inflammatory bowel disease

You may qualify if:

  • informed consent
  • documented PSC and inflammatory bowel disease

You may not qualify if:

  • under 18 years, above 80 y
  • known active malignancy
  • decompensated cirrhosis
  • patients who cannot sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Related Publications (1)

  • Laish I, Katz H, Stein A, Liberman M, Naftali T, Kitay-Cohen Y, Biron-Shental T, Konikoff FM, Amiel A. Telomere dysfunction in peripheral blood lymphocytes from patients with primary sclerosing cholangitis and inflammatory bowel disease. Dig Liver Dis. 2015 Sep;47(9):790-6. doi: 10.1016/j.dld.2015.05.002. Epub 2015 May 13.

    PMID: 26048252DERIVED

MeSH Terms

Conditions

Cholangitis, SclerosingInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

CholangitisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal Diseases

Central Study Contacts

Ido Laish, MD

CONTACT

+972-549477261ido.laish@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Md.

Study Record Dates

First Submitted

July 10, 2013

First Posted

September 25, 2014

Study Start

February 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 25, 2014

Record last verified: 2014-09

Locations

IL(1)