NCT07047937

Brief Summary

Abstract Background: Early detection of gastric cancer is crucial for improving patient survival rates. Currently, the primary method for diagnosing early-stage gastric cancer is endoscopy, which has various limitations. Additionally, single laboratory tests continue to fall short of the requirements for early screening. This study aims to develop a machine learning (ML) model using clinical data to predict early-stage gastric cancer and apply SHapley Additive exPlanation (SHAP) values to explain the ML model. Methods: This study involved patients who provided gastric tissue samples at Wenzhou Central Hospital from 2019 to 2023. The investigators gathered various laboratory test results from these patients. The investigators constructed and evaluated nine ML models to predict early-stage gastric cancer, using the area under the curve (AUC), accuracy, and sensitivity to assess their performance. For the most effective prediction model, The investigators utilized the SHAP method to determine the features' importance and explain the ML model.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

June 28, 2025

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2025

Completed
Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

3 days

First QC Date

June 4, 2025

Last Update Submit

June 27, 2025

Conditions

Keywords

early detection of cancerearly gastric cancermachine learningprediction modelSHapley Additive exPlanation (SHAP)

Outcome Measures

Primary Outcomes (1)

  • Explainable machine learning for predicting early gastric cancer

    The area under the ROC curve (AUC) was used as the primary outcome measure

    From June 2025 to July 2025

Secondary Outcomes (1)

  • Explainable machine learning for predicting early gastric cancer

    From June 2025 to July 2025

Other Outcomes (1)

  • Explainable machine learning for predicting early gastric cancer

    From June 2025 to July 2025

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all patients with a gastric tissue pathology result are included,1,085 patients were included in the study

You may qualify if:

  • all patients with a gastric tissue pathology result are included

You may not qualify if:

  • unclear or incomplete pathology results
  • significant missing laboratory data
  • progressive and advanced gastric cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wenzhou Central Hospital

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in gastrointestinal surgery

Study Record Dates

First Submitted

June 4, 2025

First Posted

July 2, 2025

Study Start

June 28, 2025

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

July 2, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

All IPD collected throughout the trial.

Shared Documents
STUDY PROTOCOL
Time Frame
Approximately from August 1, 2025 to November 1, 2025.
Access Criteria
Log in to the clinical trial public management platform, and researchers can query the original research records and data of the research plan on this platform.
More information

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