Telomere Length and Other Parameters of Telomere Dysfunct... | NCT02247622

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

NCT02247622

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Sep 25, 2014Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Primary Sclerosing Cholangitis
Inflammatory Bowel Disease

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Sep 2014Estimated

Completion Date

Sep 2014Estimated

First Submitted Date

Jul 10, 2013

First Submission Date that Met QC Criteria

Sep 19, 2014

First Posted Date

Sep 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2014

Last Update Posted Date

Sep 25, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy control
IBD		patients with inflammatory bowel disease, study group
PSC		patients with primary sclerosing cholangitis, study group

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Telomere length		1.5 years

Secondary Outcomes

Measure	Description	Time Frame
number of cells with increased telomerase RNA component (TERC) expression		1.5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with primary sclerosing cholangitis and inflammatory bowel disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ido Laish, MD	Contact	+972-549477261		ido.laish@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir Medical Center	Recruiting	Kfar Saba			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26048252	Derived	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.

ID	Term
D015209	Cholangitis, Sclerosing
D015212	Inflammatory Bowel Diseases

ID	Term
D002761	Cholangitis
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases