HCC Staging Modified by Tumor Micronecrosis

Sponsor

Zhejiang University (Other)

Overall Status

Completed

CT.gov ID

NCT05739110

Collaborator

Huizhou Municipal Central Hospital (Other), Second Affiliated Hospital of Nanchang University (Other), Meng Chao Hepatobiliary Hospital of Fujian Medical University (Other)

1,100

Enrollment

Locations

Actual Duration (Months)

550

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Behavioral: tumor micronecrosis

Study Design

Study Type:

Observational

Actual Enrollment :

1100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jul 15, 2022

Actual Primary Completion Date :

Dec 1, 2022

Actual Study Completion Date :

Jan 15, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Overall survival [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.

Secondary Outcome Measures

Disease-free survival [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the First Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310003
2	the First Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310009