NCT02313649

Brief Summary

This study will evaluate how liver stiffness measurements made with ShearWave™ Elastography (SWE) correspond with a biopsy result (currently the gold standard). The population that will be evaluated are Chinese patients infected with the Hepatitis B virus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
447

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

15 active sites

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

December 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2014

Completed
1.3 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 19, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

December 8, 2014

Last Update Submit

April 18, 2016

Conditions

Liver Fibrosis

Keywords

liverfibrosiselastographyShearWave Elastographyultrasound

Outcome Measures

Primary Outcomes (1)

  • Areas under the ROC curves for the ability of SWE measurements to predict at least significant fibrosis (Metavir F≥2), at least severe fibrosis (Metavir F≥3), and liver cirrhosis (Metavir F=4).

    This will be determined by histological examination of liver biopsy

    Within 12 months of the study start date

Secondary Outcomes (1)

  • Sensitivity, specificity, positive and negative predictive values of SWE to predict at least significant fibrosis (Metavir F≥2), at least severe fibrosis (Metavir F≥3), and liver cirrhosis (Metavir F=4).

    Within 12 months of the study start date

Eligibility Criteria

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

Chinese patients with chronic viral hepatitis B admitted for the realization of an intercostal liver biopsy in defined investigator centers.

You may qualify if:

  • Patients undergoing a liver ultrasound exam due to confirmed Hepatitis B infection ,
  • Patients having reached the age of majority in China,
  • Patients with a liver biopsy for histological evaluation of liver fibrosis, performed within 3 months after the SWE measurement date, and having the recommended quality criterion:
  • minimal length of biopsy samples of 15 mm, stored in paraffin
  • Minimal number of portal tracts of 6 per biopsy samples
  • Patients of Chinese ethnic origin

You may not qualify if:

  • Any patient presenting with combined etiologies of chronic liver diseases, including non-Hepatitis B viral infection（Hepatitis A, C, D, E, chronic alcoholic liver disease, hemochromatosis, autoimmune hepatitis, etc)
  • History of antiviral therapy at any time
  • Any patient presenting with a co-infection of HIV
  • Any patient presenting with combined liver malignant tumor
  • Previous liver transplantation
  • Pregnant women
  • Any patient with combined hepatic congestive condition such as Budd Chiari Syndrome, congestive heart failure, chronic constrictive pericarditis…
  • Any patient combined with intrahepatic cholestasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

People's Liberation Army General（301）Hospital

Beijing, China

Location

West China Hospital, Sichuan University

Chengdu, China

Location

1st Affiliated Hospital, Sun Yat-Sen University

Guangzhou, China

Location

3rd Affiliated Hospital, Sun Yat-Sen University

Guangzhou, China

Location

GuangZhou 8th People's Hospital

Guangzhou, China

Location

1st Affiliated Hospital, Haerbin Medical University

Haerbin, China

Location

1st Affiliated Hospital, ZheJiang University

Hangzhou, China

Location

YunNan Province Second People's Hospital

Kunming, China

Location

2nd Affiliated Hospital, Lanzhou University

Lanzhou, China

Location

Jiangsu Provincial Hospital

Nanjing, China

Location

Shanghai 1st People's Hospital

Shanghai, China

Location

Shengjing Hospital of Chinese Medical University

Shenyang, China

Location

1st Affiliated Hospital, XiAn Transportation University

Xi'an, China

Location

Xijing Hospital

Xi'an, China

Location

Isolation Hospital, HeNan Province

Zhengzhou, China

Location

Related Publications (1)

  • Wang K, Lu X, Zhou H, Gao Y, Zheng J, Tong M, Wu C, Liu C, Huang L, Jiang T, Meng F, Lu Y, Ai H, Xie XY, Yin LP, Liang P, Tian J, Zheng R. Deep learning Radiomics of shear wave elastography significantly improved diagnostic performance for assessing liver fibrosis in chronic hepatitis B: a prospective multicentre study. Gut. 2019 Apr;68(4):729-741. doi: 10.1136/gutjnl-2018-316204. Epub 2018 May 5.

    PMID: 29730602DERIVED

MeSH Terms

Conditions

Liver CirrhosisFibrosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ping Liang

    People's Liberation Army General（301）Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 10, 2014

Study Start

December 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

CN(15)