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OpenTrials
Completed

NCT Number: NCT05739110

HCC Staging Modified by Tumor Micronecrosis

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.

Completed

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tumor micronecrosis

Behavioral

whether HCC patients have tumor micronecrosis or not

Primary outcomes

  1. Overall survival

    Time frame: 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 outcomes

  1. Disease-free survival

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Collaborators

  • Huizhou Municipal Central Hospital
  • Meng Chao Hepatobiliary Hospital of Fujian Medical University
  • Second Affiliated Hospital of Nanchang University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 22, 2023
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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