Interpretable Machine Learning Models for Prognosis in Gastric Cancer Patients

August 9, 2024 updated by: Chang-Ming Huang, Prof.

Development and Validation of Interpretable Machine Learning Models for Prognosis in Gastric Cancer Patients: a Multicenter Retrospective Study

This multicenter, retrospective cohort study aimed to develop and validate an explainable prediction model for prognosis after gastrectomy in patients with gastric cancer.

Study Overview

Status

Completed

Conditions

Detailed Description

This multicenter, retrospective cohort study aimed to develop and validate an explainable prediction model for prognosis after gastrectomy in patients with gastric cancer. The study included patients who underwent radical gastrectomy for primary gastric or gastroesophageal junction cancer across multiple institutions in China.

The primary objective was to create a machine learning-based model to predict postoperative outcomes following gastrectomy, using readily available clinical and pathological parameters. The main outcome of interest was early recurrence within 2 years after surgery, which significantly impacts overall prognosis.

The study employed various machine learning algorithms to develop prediction models, which were then compared and validated. Model performance was assessed through measures such as area under the receiver operating characteristic curve (AUC), calibration, and Brier score. The SHapley Additive exPlanations (SHAP) method was used to interpret the model and rank feature importance.

This research aims to provide clinicians with a tool for identifying patients at higher risk of poor postoperative outcomes who may benefit from more intensive post-operative monitoring and early intervention strategies, potentially improving prognosis for gastric cancer patients.

Study Type

Observational

Enrollment (Actual)

18000

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

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Chang-ming Huang

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study includes adult patients of all genders who were diagnosed with primary gastric or gastroesophageal junction adenocarcinoma and underwent radical gastrectomy at participating institutions in China. The study population represents a diverse group of gastric cancer patients, varying in age, tumor stage, and treatment approaches, including those who received neoadjuvant therapy. This cohort aims to provide a comprehensive representation of gastric cancer patients treated with curative intent, allowing for the development and validation of prognostic models applicable to a wide range of clinical scenarios.

Description

Inclusion Criteria:

  • Patients diagnosed with primary gastric or gastroesophageal junction cancer
  • Underwent radical gastrectomy
  • Complete clinical and pathological data available

Exclusion Criteria:

  • Presence of distant metastases before surgery
  • Non-adenocarcinoma histology
  • Incomplete follow-up data

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: Up to 5 years after surgery
Assessment of overall survival outcomes in gastric cancer patients after gastrectomy.
Up to 5 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Recurrence
Time Frame: Within 2 years after surgery
Incidence of cancer recurrence within 2 years after gastrectomy.
Within 2 years after surgery
Late Recurrence
Time Frame: From 2 years up to 5 years after surgery
Incidence of cancer recurrence occurring more than 2 years after gastrectomy.
From 2 years up to 5 years after surgery
Postoperative Complications
Time Frame: Within 30 days after surgery
Incidence and severity of complications following gastrectomy.
Within 30 days after surgery
Neoadjuvant Treatment Efficacy
Time Frame: From initiation of neoadjuvant therapy to surgery (typically 2-3 months)
Assessment of tumor response to neoadjuvant therapy before gastrectomy.
From initiation of neoadjuvant therapy to surgery (typically 2-3 months)
5-Year Survival Rate
Time Frame: 5 years after surgery
Percentage of patients alive 5 years after gastrectomy.
5 years after surgery

Collaborators and Investigators

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

Sponsor

Chang-Ming Huang, Prof.

Investigators

  • Principal Investigator: Chang-Ming Huang, MD, Fujian Medical University Union Hospital

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)

June 1, 2024

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 6, 2024

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

August 9, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 9, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024KY154

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.

Clinical Trials on Stomach Neoplasms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe