HCC Staging Modified by Tumor Micronecrosis

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05739110
• Other study ID #: HCCNSTAGE
• Status: Completed
• Start date: July 15, 2022
• Est. completion date: January 15, 2023

Study information

• Verified date: February 2023
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: January 15, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Behavioral:
• tumor micronecrosis
whether HCC patients have tumor micronecrosis or not

Locations

Country	Name	City	State
China	the First Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	the First Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (4)

Lead Sponsor	Collaborator
Zhejiang University	Huizhou Municipal Central Hospital, Meng Chao Hepatobiliary Hospital of Fujian Medical University, Second Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease-free survival	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