Model for Prognosis of Elderly Gastric Cancer Patients

NCT ID: NCT06393153

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-04-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stomach Neoplasms Aged

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang-Ming Huang, Prof.

OTHER

Sponsor Role lead

Responsible Party

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Chang-Ming Huang, Prof.

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chang-Ming Huang, M.D

Role: PRINCIPAL_INVESTIGATOR

Fujian Medical University Union Hospital

Locations

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Department of Gastric Surgery, Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status

Countries

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China

Other Identifiers

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2024KY074

Identifier Type: -

Identifier Source: org_study_id

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