NCT06550739

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,053

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

August 7, 2024

Last Update Submit

August 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Survival status

    Patient survival or death

    April 31, 2024

Study Arms (2)

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.

Other: Randomization

validation set

Validate the effectiveness of the model

Other: Randomization

Interventions

Randomly divide the data into a training set and a validation set in a 7:3 ratio

training setvalidation set

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • (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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chongqing University Cancer Hospital

Chongqing, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Random Allocation

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 7, 2024

First Posted

August 13, 2024

Study Start

January 1, 2019

Primary Completion

December 31, 2020

Study Completion

April 30, 2024

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations