NCT02132351

Brief Summary

Due to the limitations and the invasive nature of liver biopsy, there has been extensive interest in developing non-invasive tests to measure liver fibrosis (1). These are alternatives to liver biopsy that can be used in clinical practice, with benefits in terms of cost, risk, and patient convenience (2). Clinically applicable non-invasive tests include radiological studies, transient elastography (TE), and serum markers. We aim at studying acceptability, reliability, applicability and practical aspects of invasive and noninvasive methods for assessment of hepatic fibrosis and cirrhosis among hepatologists.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
717

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 11, 2016

Status Verified

April 1, 2016

Enrollment Period

2.7 years

First QC Date

May 5, 2014

Last Update Submit

April 7, 2016

Conditions

CirrhosisFibrosis

Outcome Measures

Primary Outcomes (1)

  • Hepatic fibrosis

    Percentage of hepatologists accepting invasive versus non-invasive methods for assessment of hepatic fibrosis and cirrhosis.

    3 years

Secondary Outcomes (3)

  • Trust in non-invasive methods

    3 years

  • use of non-invasive methods

    3 years

  • combining non-invasive methods

    3 years

Study Arms (1)

Hepatologists

Doctors working as hepatologists

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hepatologists

You may qualify if:

  • hepatologists

You may not qualify if:

  • Non hepatologists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar Uinversity

Cairo, Cairo Governorate, 11884, Egypt

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed Alboraie, M.Sc

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post graduate researcher

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 7, 2014

Study Start

August 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 11, 2016

Record last verified: 2016-04

Locations

EG(1)