NCT06208046

Brief Summary

In this study, elderly patients with gastric cancer who underwent radical gastrectomy in Union Hospital Affiliated to Fujian Medical University from 2012 to 2018 were included as a derived cohort, and the training set and internal validation set were randomly divided by 4:1. Machine learning strategies of random forest, decision tree and support vector machine are used to construct survival prediction model. Each model was tested in an internal validation set and an external validation set consisting of patients from two other large medical centers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,187

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 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

July 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 5, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

January 5, 2024

Last Update Submit

January 5, 2024

Conditions

Keywords

Gastric CancerElderlyOxidative StressMachine LearningOverall Survival

Outcome Measures

Primary Outcomes (1)

  • 5-year overall survival

    Survival status at 5 years: survival, death, survival with tumor, deletion.

    5 years or 60 months.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This retrospective prognostic study encompassed patients aged 65 or older who underwent radical gastrectomy for GC from January 2012 to April 2018. The study involved a derivation cohort and an external validation cohort.

You may qualify if:

  • (1) GC diagnosis confirmed by abdominal computed tomography (CT) or biopsy; (2) age ≥65 years at diagnosis; (3) underwent radical surgical resection without evidence of distant metastasis; and (4) availability of complete clinical and pathological data.

You may not qualify if:

  • (1) postoperative pathology confirming non-gastric primary tumors; (2) distant metastasis; (3) incomplete clinical data; and (4) other concurrent malignancies within five years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

Related Publications (1)

  • Zhang XQ, Huang ZN, Wu J, Zheng CY, Liu XD, Huang YQ, Chen QY, Li P, Xie JW, Zheng CH, Lin JX, Zhou YB, Huang CM. Development and validation of a prognostic prediction model for elderly gastric cancer patients based on oxidative stress biochemical markers. BMC Cancer. 2025 Feb 1;25(1):188. doi: 10.1186/s12885-025-13545-x.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Huang Chang-Ming, Prof.

    Fujian Medical University Union Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 5, 2024

First Posted

January 17, 2024

Study Start

July 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 4, 2024

Last Updated

January 17, 2024

Record last verified: 2024-01

Locations