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临床试验/NCT07386639
NCT07386639已完成不适用

Gender-Specific Prediction Models for Hepatocellular Carcinoma Metastasis: A Machine Learning-Based Retrospective Cohort Study

Tongji University0 个研究点目标入组 19,019 人开始时间: 2004年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19,019
主要终点
Presence of Distant Metastasis at Diagnosis

研究概览

简要总结

This study looked at whether male and female patients with liver cancer (hepatocellular carcinoma, HCC) have different risks of the cancer spreading to distant parts of the body (distant metastasis). Liver cancer is much more common in men than in women, and women often have better survival rates. However, it was unclear if the factors that predict this spread are the same for both sexes.

To answer this question, researchers analyzed information from a large, national cancer database (SEER) from 2004 to 2022, including 19,019 patients diagnosed with liver cancer. They studied factors like age, race, tumor stage, treatment received, and where patients lived. The team used advanced computer models (machine learning) to build separate prediction tools for men and women to estimate their risk of distant metastasis at the time of diagnosis.

详细描述

Study Design and Objective:

This was a retrospective, population-based cohort study utilizing data from the Surveillance, Epidemiology, and End Results (SEER) database. The primary objective was to systematically compare the incidence and identify sex-specific determinants of distant metastasis in patients with hepatocellular carcinoma (HCC). A secondary objective was to develop and validate separate, high-performance machine learning (ML) prediction models for distant metastasis risk tailored to male and female patients.

Data Source and Participants:

Data were extracted from 22 SEER registries covering patients diagnosed with HCC between 2004 and 2022. Inclusion required a pathological diagnosis of HCC. Key exclusion criteria were: missing data on race, marital status, tumor grade, or surgical status; non-first primary malignancy; and incomplete TNM staging data. After applying criteria, 19,019 patients were included in the final analysis (14,575 males, 4,444 females).

Variables and Definitions:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pathologically confirmed diagnosis of Hepatocellular Carcinoma (HCC).
  • Diagnosis year between 2004 and 2022, inclusive.
  • Case identified within the 22 registries of the Surveillance, Epidemiology, and End Results (SEER) database.

排除标准

  • Missing information on race, marital status, tumor grade, or surgical status.
  • Non-first primary malignancy or presence of multiple primary tumors.
  • Incomplete TNM staging data.

研究组 & 干预措施

MALE and Female HCC Patients

A cohort of male patients (n=14,575) diagnosed with hepatocellular carcinoma (HCC) between 2004 and 2022, identified from the SEER database. This group was analyzed separately to identify sex-specific determinants and build a prediction model for distant metastasis.;A cohort of female patients (n=4,444) diagnosed with hepatocellular carcinoma (HCC) between 2004 and 2022, identified from the SEER database. This group was analyzed separately to identify sex-specific determinants and build a prediction model for distant metastasis.

结局指标

主要结局

Presence of Distant Metastasis at Diagnosis

时间窗: At completion of data analysis (2024).

The area under the receiver operating characteristic curve (AUC) of the best-performing machine learning model for predicting distant metastasis in the male cohort, evaluated on the internal testing set.

次要结局

  • Presence of distant metastasis at initial diagnosis(At diagnosis (Data from SEER registries covering years 2004-2022).)

研究者

发起方
Tongji University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Linlin Liu

Clinical Professor

Tongji University

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