NCT02131831

Brief Summary

There are several factors that influence telomere length in patients with cirrhosis, such as metabolic derangements and infectious etiologies, The aim of the study is to compare telomere length and other parameters related to genetic instability in telomere/ telomerase system, in peripheral blood lymphocytes in cirrhosis from different etiologies.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2014

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

First Submitted

Initial submission to the registry

April 26, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

1.5 years

First QC Date

April 26, 2014

Last Update Submit

September 15, 2014

Conditions

Cirrhosis

Keywords

telomeretelomerasecirrhosis

Outcome Measures

Primary Outcomes (1)

  • telomerase activity

    number of copies of telomerase in peripheral blood lymphocytes, as determined by FISH

    baseline

Study Arms (1)

cirrhosis

Eligibility Criteria

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

patients with cirrhosis

You may qualify if:

  • cirrhotic patients from different etiologies

You may not qualify if:

  • decompensated cirrhosis (Child C)
  • age under 18 years
  • any known malignancy, including hepatocellular carcinoma
  • patient that are unable to sign for informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ido Laish, MD

CONTACT

ido.laish@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phsician in gastroenterology institute

Study Record Dates

First Submitted

April 26, 2014

First Posted

May 6, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 16, 2014

Record last verified: 2014-09

Locations

IL(1)