Comprehensive Prognostic Model: The Study Introduces a Novel Prognostic Model That Incorporates a Wide Range of Clinical and Laboratory Variables, Providing a More Holistic Approach to Predicting Overall Survival in HCC Patients

August 8, 2024 updated by: Haike Lei

Development and Validation of a New Prognostic System for Patients With Hepatocellular Carcinoma: A Cohort Study in China

Background: Hepatocellular carcinoma (HCC) is a significant health problem in China, with high incidence and mortality rates. This study aimed to identify the prognostic factors of elderly HCC patients in southwest China and construct a new prognostic model for predicting overall survival (OS).

Methods: This retrospective cohort study collected clinical data from 958 patients with liver cancer on January 1, 2019, and December 12, 2020. The Cox regression model was used to test the significance of all available variables as prognostic factors of OS. Independent prognostic factors were identified based on multivariable analysis to model nomograms. The concordance index (C-index), the area under the receiver operating characteristic (AUC), the Time-dependent C-index, the Time-dependent AUC, the calibration curve, and decision curve analysis (DCA) were measured to assess the model performance of the nomogram.

Conclusions: The comprehensive risk prediction model for OS in HCC patients developed through this retrospective cohort study offers a promising avenue for improving clinical outcomes and patient care.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1053

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Chongqing, China
        • Chongqing University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The data used in the retrospective cohort study were obtained from 958 patients with HCC from the Chongqing University Cancer Hospital tumor database between Jan 1, 2019, and Dec 12, 2020.

Description

Inclusion Criteria:

  • (1) age ≥ 18 years; (2) had pathologically confirmed primary liver cancer; (3) received the main treatment in our hospital; (4) provided baseline clinical information and follow-up information; (5) completed the entire course of radiotherapy, chemotherapy and targeted therapy.

Exclusion Criteria:

  • no follow-up records and a history of cancer treatments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
training set
Patients were randomly divided into two groups: a training group of 671 individuals (approximately 70% of the data) and a validation group of 287 individuals (approximately 30% of the data).The nomogram model was developed using the training cohort.
Randomly divide the data into a training set and a validation set in a 7:3 ratio
validation set
Validate the effectiveness of the model
Randomly divide the data into a training set and a validation set in a 7:3 ratio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival status
Time Frame: April 31, 2024
Patient survival or death
April 31, 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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