Exploration of Noninvasive Differential Diagnosis of Benign and Malignant Liver Tumors

July 23, 2024 updated by: Xijing Hospital

Department of Ultrasonic Medicine, The First Affiliated Hospital of Air Force Medical University

To explore an effective noninvasive method for differential diagnosis of liver tumors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A retrospective study was performed to assess the performance of certain ultrasound-based parameters, in distinguishing benign from malignant with liver biopsy as the gold standard. Demographic data, clinical information and serological data were obtained from participants who were retrospectively enrolled. Receiver operating characteristic (ROC) curve analysis was conducted, including calculation of the optimal area under the ROC curve (AUC), to assess the performance of these measures in distinguishing between benign and malignant in patients with or without chronic liver disease.

Study Type

Observational

Enrollment (Estimated)

200

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
    • Xi'an
      • Xi'an, Xi'an, China, 710032

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

No

Sampling Method

Non-Probability Sample

Study Population

A total of 200 patients whose pathological diagnoses were confirmed by US-guided liver biopsy or surgery and who underwent preoperative conventional US between January 2018 and November 2025 were enrolled in the study.

Description

Inclusion Criteria:

(1) age 18-70 years; (2) liver examination performed for all patients prior to US-guided liver biopsy or surgery; (3) tumor can be visualized in conventional US; (4) largest tumor sectional area saved in DICOM format for use in later analyses; (5) a histopathological diagnosis made either from US-guided liver biopsy or surgical resection; (6) suitable routine clinical and US data obtained within 7 days of the histopathological diagnosis.

Exclusion Criteria:

(1) unavailable pathological diagnosis; (2) liver metastatic tumors; (3) poor quality US images; and (4) a past history of surgical resection, percutaneous local ablation, radiation, transarterial and systemic therapies or liver transplantation.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
with chronic liver disease
patients with hepatitis B virus, hepatitis C virus and other chronic liver disease.
Diagnostic test: with chronic liver disease
patients with hepatitis B virus，hepatitis C virus, or other chronic liver disease
without chronic liver disease
patients without hepatitis B virus, hepatitis C virus and other chronic liver disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The differential diagnosis of liver tumors
Time Frame: 2018.01-2025.12
Multimodal ultrasound is of great value in the differential diagnosis of liver tumors
2018.01-2025.12

Collaborators and Investigators

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

Sponsor

Xijing Hospital

Investigators

  • Study Chair: Zhou Huihui, M.M., Department of Ultrasonic Medicine, The First Affiliated Hospital of Air Force Medical University

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)

January 1, 2018

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

July 23, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2024

Last Update Submitted That Met QC Criteria

July 23, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-20180101-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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