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A Nomogram for Evaluating Significant Liver Fibrosis in Patients With Chronic Hepatitis B Virus Infection

Sponsor
Xiangya Hospital of Central South University (Other)
Overall Status
Completed
CT.gov ID
NCT05560503
Collaborator
(none)
259
Enrollment
64.9
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Liver fibrosis is the key step for progression to cirrhosis and liver cancer in patients with chronic hepatitis B (CHB). It is crucial to identify significant liver fibrosis in the treatment of CHB patients. Hence, the investigators aim to construct and validate a new nomogram model for evaluating significant liver fibrosis in CHB patients. The nomogram was based on a retrospective study of 259 CHB patients, who underwent liver biopsy. Through random grouping, 182 cases (70%) were included in the training set and 77 cases (30%) were included in the validation set. Biopsy pathological stage was used as the gold standard to screen the factors included in the model. The receiver operating characteristic (ROC), area under the ROC curve (AUC), calibration curve, and decision curve analysis were used to evaluate the diagnostic effect of this nomogram model. In addition, the investigators will compare the diagnostic efficiency of the new nomogram model with APRI, FIB-4, and GPR.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    259 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Establish a New Noninvasive Diagnostic Model Based on Common Clinical Indicators to Evaluate the Liver Fibrosis in Patients With Chronic Hepatitis B
    Actual Study Start Date :
    Jan 1, 2017
    Actual Primary Completion Date :
    Apr 30, 2022
    Actual Study Completion Date :
    May 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    significant liver fibrosis

    According to the Scheuer scoring system, the degree of fibrosis S2-S4 as significant liver fibrosis.
    non-significant liver fibrosis

    According to the Scheuer scoring system, the degree of fibrosis S0-S1 was defined as non-significant liver fibrosis.

    Outcome Measures

    Primary Outcome Measures

    1. Differences in demographic data and clinical test indicators between significant liver fibrosis group and non-significant liver fibrosis group [0 week]

      Demographic data include age and sex. Dlinical test indicators include albumin, total bilirubin, alanine aminotransferase, aspartate aminotransferase, γ-glutamyl transferase, alkaline phosphatase, white blood cell count, neutrophil count, hemoglobin, platelet count, prothrombin activity, international normalized ratio, activated partial thromboplastin time, alpha fetoprotein, HBV DNA, HBsAg, and HBeAg.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • meet the diagnostic standard presented in Asian-Pacific clinical practice guidelines on the management of hepatitis B.

    • HBsAg-positive for over 6 months.

    • aged 18-65 years old.

    • no gender limitation.

    Exclusion Criteria:

    • co-infection with other types of hepatitis viruses, including types A, C, D, and E.

    • co-infection with human immunodeficiency virus (HIV).

    • autoimmune hepatitis (AIH), primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), inherited metabolic liver disease, drug-induced liver injury (DILI), alcoholic liver disease, and hepatocellular carcinoma (HCC).

    • with other malignant tumor and other major systemic diseases.

    • incomplete clinical data.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Xiangya Hospital of Central South University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiangya Hospital of Central South University
    ClinicalTrials.gov Identifier:
    NCT05560503
    Other Study ID Numbers:
    • 202205120
    First Posted:
    Sep 29, 2022
    Last Update Posted:
    Sep 29, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis B
    Hepatitis B, Chronic
    Liver Cirrhosis
    Fibrosis

    Study Results

    No Results Posted as of Sep 29, 2022