Assessment of Liver Fibrosis and Prognosis in Chinese Patients With CHB Infection Using STE/STQ Elastography

NCT03530657 | Unknown DMC

• 1 other identifier: STE/STQ 2018
• Study Type: observational
• Target: 460
• Locations: 0 countries
• Sites: N/A

Brief Summary

This national multicenter prospective study is aimed to study the diagnositic performance of STE/STQ elastography in liver fibrosis and prognosis in patients with chronic hepatitis B infection.

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Degree of Liver Fibrosis

  All liver biopsies will be taken for evaluating the degree of liver fibrosis according to the METAVIRE classification. The degree of fibrosis is classified in a 0-4 scale as follows: F0: no fibrosis, F1: portal fibrosis alone, F2: portal fibrosis with rare septa, F3: portal fibrosis with many septa, and F4: cirrhosis.

  1-2 years

Secondary Outcomes (1)

• Complication rates depending on liver STE/STQ measurement values at baseline

  2 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who are recruited from primary care clinic

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 STE/STQ 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 of the conditions below will exclude patients from the study:
• Any patient presenting with combined etiologies of chronic liver diseases:，including Non hepatitis B viral infection（Hepatitis A, C, D, E）, alcoholic chronic liver disease, hemochromatosis, autoimmune hepatitis，etc
• Any patient presenting with a co-infection of HIV
• Any patient presenting with combined liver tumor
• Any patient ever received liver transplantation
• Pregnant women
• Acute hepatitis

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Liver biopsy specimens

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the Department of Medical Ultrasound

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 21, 2018
• Study Start: June 4, 2018
• Primary Completion: June 4, 2020
• Study Completion: August 1, 2021
• Last Updated: May 21, 2018

Record last verified: 2018-05