Prediction Model for Advanced Gastric Cancer in Elderly

NCT ID: NCT06467591

Last Updated: 2024-06-21

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

1436 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-05-20

Brief Summary

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This study aims to develop and validate a Nomogram (mCNS) model for predicting long-term survival in elderly patients following curative resection for advanced gastric cancer. The study is a retrospective multi-center analysis involving 924 gastric cancer patients treated at the Department of Gastrointestinal Surgery of the Affiliated Union Hospital of Fujian Medical University between 2009 and 2013, and 512 patients aged 65 and above who underwent gastric resection at the Affiliated Zhongshan Hospital of Dalian University between 2011 and 2018. 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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Data were collected from 1436 gastric cancer patients, of which 555 elderly patients with advanced gastric cancer were ultimately included after applying exclusion criteria. Patients were divided into training and testing cohorts from the Fujian Medical University Affiliated Union Hospital and Dalian University Affiliated Zhongshan Hospital. 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 utilized the Cox proportional hazards model to select key variables for predicting overall survival (OS). The study also implemented rigorous data handling procedures, including multiple imputations for missing data. The development of an online prognostic tool based on the Nomogram 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

* Confirmed as primary gastric adenocarcinoma by preoperative gastric endoscopy pathology;
* Underwent R0 laparoscopic radical gastrectomy for gastric cancer;
* Pathological stage T2-4a-N+;
* Age ≥ 65 years.

Exclusion Criteria

* Pathological stage T1 and T2N0;
* Age \< 65 years;
* Presence of peritoneal or distant metastasis confirmed before or during surgery;
* Received neoadjuvant chemotherapy before surgery;
* Remnant gastric cancer;
* Emergency surgery or palliative exploratory surgery;
* Preoperative abdominal CT scan not available or preoperative examination time \> 1 month;
* Survival time less than 1 month;
* Incomplete clinical and pathological data.
Minimum Eligible Age

65 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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2024KY076

Identifier Type: -

Identifier Source: org_study_id

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