Clinical Decision Biological Biomarker and Prognosis Prediction of Hepatocellular Carcinoma by Deep Learning

October 19, 2022 updated by: Ping Liang

A Deep Learning Model Based on Contrast-enhanced Ultrasound to Aid Clinical Decisions and Predict Biological Biomarker and Prognosis of Hepatocellular Carcinoma

Developing a deep learning model based on contrast-enhanced ultrasound (CEUS) to predict the prognosis of hepatocellular carcinoma (HCC) and aid choose operation decisions

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Collecting CEUS and clinical data of HCC from different institutions retrospectively.

Developing a deep learning model based on CEUS to predict the prognosis of HCC. Developing a deep learning model based on CEUS to choose a better operation (ablation or surgery) of HCC patients.

Then, validating the deep learning model in the prospective data.

Study Type

Observational

Enrollment (Anticipated)

1

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 Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with HCC corresponding to Ia, Ib, IIa stage (China liver cancer staging) who undergo resection or ablation.

Description

Inclusion Criteria:

  • patients with HCC (Ia, Ib, IIa stage) China liver cancer staging who underwent resection or ablation
  • without macro-vascular invasion
  • Child-Pugh A/B grade
  • HCC is proved by pathological examination or two enhanced imaging
  • CEUS (Sonovue or Sonozoid) images are performed two weeks before the operation
  • Invasive biomarker or prognosis of HCC available
  • CEUS images are included in at least three stages (Arterial phase, Portal phase, and Late phase)

Exclusion Criteria:

  • postop follow-up loss or expired less than 3 months
  • patients with co-malignancy
  • poor images quality for analyzing

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
Recurrence-free survival (RFS)
Time Frame: Immediately after the surgery or ablation
Recurrence-free survival is defined as the time elapsed between a predefined point in time (the date of diagnosis, randomization or the intervention) and any recurrence (local, regional, or distant) or death due to any cause (death is an event).
Immediately after the surgery or ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: Immediately after the surgery or ablation
Recurrence included local tumor progression, regional recurrence, or distant recurrence.
Immediately after the surgery or ablation

Collaborators and Investigators

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

Sponsor

Ping Liang

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, 2022

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

February 13, 2022

First Submitted That Met QC Criteria

February 24, 2022

First Posted (Actual)

February 25, 2022

Study Record Updates

Last Update Posted (Actual)

October 21, 2022

Last Update Submitted That Met QC Criteria

October 19, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2022-002

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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