Follow-up Strategy of Chronic Hepatitis B for Early Detection and Diagnosis of Hepatocellular Carcinoma: A Randomized Control Trial

NCT02817685 | Unknown

• 1 other identifier: SYSU2016
• Study Type: observational
• Target: 7,660
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized control prospective study. The aim of this study is to establish an all-round and convenient follow-up strategy of Chronic Hepatitis B for early detection and diagnosis of Hepatocellular Carcinoma (HCC), by investigating whether different surveillance time intervals and surveillance methods are beneficial for chronic hepatitis B and cirrhotic patients with different risk of HCC.

Conditions

Chronic Hepatitis B

Keywords

surveillance; hepatocellular carcinoma; ultrasound; cirrhosis; chronic hepatitis B

Outcome Measures

Primary Outcomes (1)

• The incidence of Hepatocellular carcinoma

  3 year

Study Arms (6)

1

Chronic Hepatitis B patient

Other: 3 months

2

Chronic Hepatitis B patient

Other: 6 months

3

cirrhotic patient

Other: 3 months

4

cirrhotic patient

Other: 6 months

5

ultrasound-difficult patient

Other: 3 month ultrasound(US)+3 month CT/MRI+3 month US+3 month CT/MRI

6

ultrasound-difficult patient

Other: 6 months

Interventions

3 months OTHER

1; 3

6 months OTHER

2; 4; 6

3 month ultrasound(US)+3 month CT/MRI+3 month US+3 month CT/MRI OTHER

5

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic Hepatitis B patients

You may qualify if:

• HBV-Ag positive( \>6 months)
• age among 18 and 80 years

You may not qualify if:

• patients with hepatocellular carcinoma
• patients with alcoholic hepatitis or autoimmune hepatitis
• patients with severe uncontrolled disease resulting in estimated life expectance less than 1 year
• coinfection with human immunodeficiency virus(HIV)
• cannot undergo contrast-enhanced imaging
• refuse attending the study

Sponsors & Collaborators

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

Study Sites (1)

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

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic; Carcinoma, Hepatocellular; Fibrosis

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• zhongzhen zz Su, doctor

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

  STUDY DIRECTOR

Central Study Contacts

zhongzhen zz Su, doctor

CONTACT

0086-020-85252010; sp9313@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: June 29, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2020
• Last Updated: June 29, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)