NCT02143180

Brief Summary

Our study is a prospective multicenter research and the aim is to explore a variety of suitable evaluation indicators and criteria for diagnosis of diffuse liver fibrosis, to get the corresponding diagnosis threshold, with the domestic common pathological S stages as the gold standard.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ 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

May 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

May 20, 2014

Status Verified

May 1, 2014

Enrollment Period

1.6 years

First QC Date

May 16, 2014

Last Update Submit

May 16, 2014

Conditions

Chronic Hepatitis

Keywords

real-time tissue elastographyhepatic fibrosis

Outcome Measures

Primary Outcomes (1)

  • Liver Fibrosis Index (LFI)

    During the examination

Eligibility Criteria

Age5 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic hepatitis

You may qualify if:

  • \. Patient has a history of chronic hepatitis on clinical diagnosis; 2. Patient undergoed liver biopsy during study time.

You may not qualify if:

  • \. Patient cannot receive examination due to critical condition; 2. Patient refuse the examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The department of Ultrasound, the third affiliated hospital of Sun Yat-son University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Hepatitis, ChronicLiver Cirrhosis

Condition Hierarchy (Ancestors)

HepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsFibrosis

Study Officials

  • Rogqin RQ Zheng, doctor

    The department of Ultrasound, the third affiliated hospital of Sun Yat-son University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 16, 2014

First Posted

May 20, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2015

Last Updated

May 20, 2014

Record last verified: 2014-05

Locations

CN(1)