Prognostic Models for HCC Based on Tumor Micronecrosis

NCT05837065 | Unknown

• 1 other identifier: PMforHCC
• Study Type: observational
• Target: 765
• Locations: 1 country
• Sites: 1

Brief Summary

The heterogeneity of hepatocellular carcinoma (HCC) leads to the unsatisfying predicting performance of current staging systems. HCC patients with pathological tumor micronecrosis have immunosuppressive microenvironment. We aimed to develop novel prognostic models by integrating micronecrosis to more precisely predict the survival of HCC patients after hepatectomy.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Tumor micronecrosis; Nomogram

Outcome Measures

Primary Outcomes (1)

• the Harrell concordance index (C-index)

  Up to 5 years

Secondary Outcomes (1)

• the time-dependent area under the receiver operating characteristic curve(tdAUROC)

  Up to 5 years

Study Arms (2)

training cohort

HCC patients receiving curative hepatic resection

Other: observing whether HCC patients having tumor micronecrosis

validation cohort

HCC patients receiving curative hepatic resection

Other: observing whether HCC patients having tumor micronecrosis

Interventions

observing whether HCC patients having tumor micronecrosis OTHER

whether HCC patients having tumor micronecrosis or not

training cohort; validation cohort

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective study enrolled HCC patients receiving curative hepatectomy in the First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU) (n = 765)

You may qualify if:

• pathologically diagnosed as HCC;
• curative hepatectomy with R0 resection;
• conserved liver function with Child Pugh class A or B

You may not qualify if:

• with macrovascular invasion or extrahepatic metastasis;
• receiving other anti-tumor treatments such as TACE or systemic drugs;
• with other primary cancers;
• incomplete follow-up data;
• without sufficient formalin-fixed, paraffin-embedded (FFPE) specimens for micronecrosis evaluation

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Tingbo Liang, PhD

CONTACT

liangtingbo@zju.edu.cn

Qi Zhang, MD

CONTACT

13819137113; qi.zhang@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 1, 2023
• Study Start: September 15, 2022
• Primary Completion: March 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)