Assessment of FibbroScan in Diagnosing MASLD Among the Chinese Population With Obesity (MASLD)

December 2, 2024 updated by: Hongmei Zhu, The Third People's Hospital of Chengdu

The non-invasive evaluation of liver steatosis and fibrosis with FibroScan is a routinely procedure in clinical practice for people with obesity. However, there are still considerable uncertainties regarding the potential influence of confounding factors and the optimal application of cut-off values for obesity.

The goal of this observational study is to learn about the optimal application of cut-off values of for Chinese people with obesity.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • The Third People's Hospital of Chengdu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population consisted of patients aged 18 years or older who provided written informed consent and were scheduled to undergo bariatric surgery.

Description

Inclusion Criteria:

  1. Patients aged 18 years or older who provided written informed consent
  2. Patients who schedule to undergo bariatric surgery and a liver biopsy (LB) for the investigation of suspected MASLD
  3. Patients who schedule to undergo FibroScan examination

Exclusion Criteria:

  1. Patients with ascites or pregnant women
  2. Patients with any active implantable medical device (such as a pacemaker or defibrillator)
  3. Patients who have undergone liver transplantation
  4. Patients with cardiac failure and/or significant valvular disease
  5. Patients with haemochromatosis
  6. Patients who have refused to undergo LB or blood tests
  7. Patients with a confirmed diagnosis of active malignancy, or other terminal disease
  8. Patients participating in another clinical trial within the preceding 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy
Time Frame: Through study completion, an average of 1 year
Estimated using the area under the receiver operating characteristic curves for the categories of steatosis and fibrosis
Through study completion, an average of 1 year
Cut-off values
Time Frame: Through study completion, an average of 1 year
Optimal thresholds for application on people with obesity
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third People's Hospital of Chengdu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2023

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

November 27, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Estimated)

December 6, 2024

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-S-177
  • CSY-YNXM-2023-001 (Other Grant/Funding Number: The Third People's Hospital of Chengdu)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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