HCC Staging Modified by Tumor Micronecrosis

February 21, 2023 updated by: TingBo Liang, Zhejiang University

Optimizing Hepatocellular Carcinoma Disease Staging Systems by Incorporating Tumor Micronecrosis: A Multi-institutional Retrospective Study

Tumor micronecrosis is a pathological feature that reflects malignant biological behavior in hepatocellular carcinoma (HCC). This study aimed to evaluate the prognostic significance of tumor micronecrosis based on the current BCLC and TNM staging systems, and futher improve the performance of the staging models by establishing modified new staging models including tumor micronecrosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1100

Contacts and Locations

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

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • the First Affiliated Hospital, School of Medicine, Zhejiang University
      • Hangzhou, Zhejiang, China, 310009
        • the First Affiliated Hospital, School of Medicine, Zhejiang University

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This retrospective study enrolled patients who underwent liver resection from four institutions in China: the First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU) (n = 896), Mengchao Hepatobiliary Hospital of Fujian Medical University (n = 94), the Second Affiliated Hospital of Nanchang University (n = 84), and Huzhou Central Hospital (n = 36).

Description

Inclusion Criteria:

  • primary and histologically confirmed HCCs
  • patients who underwent curative liver resection

Exclusion Criteria:

  • simultaneous presence of other tumors
  • patients who had received preoperative antitumor therapies
  • no available surgical specimens for evaluating micronecrosis status
  • gross tumor necrosis and Nscore = 3

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
micronecrosis(+) group
Hepatocellular patients with tumor micronecrosis.
Behavioral: tumor micronecrosis
whether HCC patients have tumor micronecrosis or not
micronecrosis(-) group
Hepatocellular patients without tumor micronecrosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: from date after liver resection until death or last follow-up, whichever came first, assessed up to 72 months
the number of months from the date of surgery to the date of the last follow-up visit or time of death.
from date after liver resection until death or last follow-up, whichever came first, assessed up to 72 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: from date after liver resection until recurrence or last follow-up, whichever came first, assessed up to 72 months
the number of months from the date of surgery to the date of first confirmable recurrence or death
from date after liver resection until recurrence or last follow-up, whichever came first, assessed up to 72 months

Collaborators and Investigators

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

Sponsor

Zhejiang University

Collaborators

Huizhou Municipal Central Hospital
Second Affiliated Hospital of Nanchang University
Meng Chao Hepatobiliary Hospital of Fujian 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)

July 15, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

January 15, 2023

Study Registration Dates

First Submitted

February 11, 2023

First Submitted That Met QC Criteria

February 21, 2023

First Posted (Estimate)

February 22, 2023

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCCNSTAGE

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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