Exploration of Noninvasive Differential Diagnosis of Benign and Malignant Liver Tumors

NCT ID: NCT06524557

Last Updated: 2024-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2025-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Liver Tumor

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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with chronic liver disease

patients with hepatitis B virus, hepatitis C virus and other chronic liver disease.

with chronic liver disease

Intervention Type DIAGNOSTIC_TEST

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.

No interventions assigned to this group

Interventions

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with chronic liver disease

patients with hepatitis B virus,hepatitis C virus, or other chronic liver disease

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhou Huihui, M.M.

Role: STUDY_CHAIR

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

Locations

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Xijing Hosptial

Xi'an, Xi'an, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhou Huihui, M.M.

Role: CONTACT

15209239680

Facility Contacts

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Zhou Huihui, M.M.

Role: primary

15209239680

References

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Zhou H, Sang L, Sun Y, Gong X, Zhang J, Liu L, Wei J, Jiao W, Yu M. Performance of Ultrasonography-Based Fractal Parameters in Distinguishing Hepatocellular Carcinoma From Intrahepatic Cholangiocarcinoma. Ultrason Imaging. 2025 Jul;47(3-4):115-124. doi: 10.1177/01617346251330257. Epub 2025 Apr 15.

Reference Type DERIVED
PMID: 40231713 (View on PubMed)

Other Identifiers

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KY-20180101-3

Identifier Type: -

Identifier Source: org_study_id

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