Prediction of Significant Liver Fibrosis

NCT ID: NCT06509230

Last Updated: 2024-07-19

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

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-20

Study Completion Date

2026-12-31

Brief Summary

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The deep learning method based on convolutional neural network (CNN) was used to extract the relevant features of liver fibrosis classification from the multi-modal information of digital pathological sections, clinical parameters and biomarkers of a large number of existing cases of liver puncture, and the U-Net architecture of CNN was used to segment and extract the features of clinical medical images.

Detailed Description

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Patients with chronic hepatitis B underwent B-ultrasound-guided liver biopsy, and were divided into mild liver fibrosis group (fibrosis grade 0-1, S1), significant liver fibrosis group (fibrosis grade 2, S2), advanced liver fibrosis group and early cirrhosis group (fibrosis grade 3-4, S3-4) according to the pathological results.In this study, 200 patients with different degrees of liver fibrosis and 200 normal volunteers were collected from 2018 to 2022, and their clinical biochemical data, imaging data and peripheral blood samples were collected.The pathological microenvironment characteristics, imaging characteristics, clinical parameter characteristics and other data of patients were extracted, and the distillation learning method based on teacher-student model was adopted to develop and construct a multi-modal big data analysis model for accurate grading of liver fibrosis, so as to achieve a non-invasive intelligent grading diagnosis system for liver fibrosis.

Conditions

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Liver Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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mild fibrosis

S0-1

Intervention Type OTHER

The fibrosis grades were grouped without drug intervention

significant liver fibrosis

S2

Intervention Type OTHER

The fibrosis grades were grouped without drug intervention

Advanced liver fibrosis

S3-4

Intervention Type OTHER

The fibrosis grades were grouped without drug intervention

Interventions

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The fibrosis grades were grouped without drug intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age of 18-60 years old
2. The diagnosis of chronic hepatitis B is in line with the diagnostic criteria of China's 2019 Chronic Hepatitis B Prevention and Treatment Guidelines, and the diagnosis of non-alcoholic fatty liver is in line with the Asian Pacific Hepatology Association guidelines
3. Imaging showed no liver cancer

Exclusion Criteria

1. There are contraindications for liver biopsy
2. Liver pathology did not meet the criteria
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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East China University of Science and Technology

OTHER

Sponsor Role collaborator

Huang Haijun

OTHER

Sponsor Role lead

Responsible Party

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Huang Haijun

Protomedicus

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Haijun Huang

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haijun Huang

Role: CONTACT

13758186635

Facility Contacts

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Haijun Huang

Role: primary

13758186635

Other Identifiers

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KY2024072

Identifier Type: -

Identifier Source: org_study_id

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