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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05739110
Other study ID # HCCNSTAGE
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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