HCC Staging Modified by Tumor Micronecrosis

NCT05739110 | Completed

• 1 other identifier: HCCNSTAGE
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; Tumor micronecrosis; BCLC; TNM; Disease staging

Outcome Measures

Primary Outcomes (1)

• Overall survival

  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 Outcomes (1)

• Disease-free survival

  from date after liver resection until recurrence or last follow-up, whichever came first, assessed up to 72 months

Study Arms (2)

micronecrosis(+) group

Hepatocellular patients with tumor micronecrosis.

Behavioral: tumor micronecrosis

micronecrosis(-) group

Hepatocellular patients without tumor micronecrosis.

Interventions

tumor micronecrosis BEHAVIORAL

whether HCC patients have tumor micronecrosis or not

micronecrosis(+) group

Eligibility Criteria

• Age: 18 Years - 80 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 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang University: lead
• Huizhou Municipal Central Hospital: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• Meng Chao Hepatobiliary Hospital of Fujian Medical University: collaborator

Study Sites (2)

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

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

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: February 11, 2023
• First Posted: February 22, 2023
• Study Start: July 15, 2022
• Primary Completion: December 1, 2022
• Study Completion: January 15, 2023
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)