Hepatocellular Carcinoma Clinical Trial
Official title:
Optimizing Hepatocellular Carcinoma Disease Staging Systems by Incorporating Tumor Micronecrosis: A Multi-institutional Retrospective Study
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 |
Verified date | February 2023 |
Source | Zhejiang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Zhejiang University | Huizhou Municipal Central Hospital, Meng Chao Hepatobiliary Hospital of Fujian Medical University, Second Affiliated Hospital of Nanchang University |
China,
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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