Model for Prognosis of Elderly Gastric Cancer Patients

Stomach Neoplasms Clinical Trial

Official title:

Development and Validation of a Machine Learning Model for Predicting the Prognosis of Elderly Gastric Cancer Patients: A Multi-Center Study in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06393153
• Other study ID #: 2024KY074
• Status: Completed
• Start date: January 1, 2024
• Est. completion date: April 20, 2024

Study information

• Verified date: April 2024
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to develop and validate a Random Survival Forest (RSF) model for predicting long-term survival in elderly patients following curative resection for gastric cancer. The study is a retrospective multi-center analysis involving patients aged 75 and above who underwent gastric resection from January 2009 to December 2018 at nine top-tier hospitals in China. An online prognostic tool is introduced to assist clinicians in predicting patient prognosis and customizing treatment and follow-up strategies.

Description:

This retrospective multi-center study focuses on the development and validation of a predictive model for elderly gastric cancer patients. Data were collected from 16,344 gastric cancer patients, with 1,202 elderly patients ultimately included after applying exclusion criteria. Patients were randomly divided into training and testing cohorts in a 7:3 ratio. The study was approved by the institutional review boards with a waiver of informed consent due to the use of anonymized secondary data.

The analysis employs the Random Survival Forest (RSF) method, incorporating variable importance and minimal depth techniques to select key variables for predicting overall survival (OS) and disease-free survival (DFS). The study also implements rigorous data handling procedures, including multiple imputations for missing data.

The development of an online prognostic tool based on the RSF model is part of the project, designed to provide real-time survival predictions through a user-friendly interface for clinical application.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1202
• Est. completion date: April 20, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 75 years or older.

• Histologically confirmed diagnosis of gastric cancer.

• Patients who have undergone curative gastrectomy.

Exclusion Criteria:

• Patients with non-primary gastric malignancies.

• Pathological confirmation of metastatic disease (M1).

• Incomplete follow-up data or loss to follow-up.

Related Conditions & MeSH terms

• Aged
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Department of Gastric Surgery, Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Chang-Ming Huang, Prof.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-Year Overall Survival	The proportion of patients who are alive at five years after treatment for elderly gastric cancer patients.	5 years or 60 months.
Primary	5-Year Disease-Free Survival	The proportion of patients who have survived without any signs or symptoms of gastric cancer for five years after the initial treatment.	5 years or 60 months.
Secondary	3-Year Overall Survival	The proportion of patients who have survived without any signs or symptoms of gastric cancer for 3 years after the initial treatment.	3 years or 36 months.
Secondary	1-Year Overall Survival	The proportion of patients who have survived without any signs or symptoms of gastric cancer for 1 years after the initial treatment.	1 years or 12 months.
Secondary	3-Year Disease-Free Survival	The proportion of patients who have survived without any signs or symptoms of gastric cancer for 3 years after the initial treatment.	3 years or 36 months.
Secondary	1-Year Disease-Free Survival	The proportion of patients who have survived without any signs or symptoms of gastric cancer for 1 years after the initial treatment.	1 years or 12 months.