NCT06690268

Brief Summary

This study focuses on developing an advanced model that combines clinical information, imaging, and pathology data to predict the likelihood of cancer returning after surgery in patients with locally advanced gastric cancer. By using artificial intelligence (AI), this model analyzes various data sources to create a more accurate prediction of recurrence risk, which can help doctors, patients, and families better understand the chances of recurrence. This AI-driven approach allows healthcare providers to make more informed decisions about personalized follow-up care and potential additional treatments to improve patient outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2024

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

2.8 years

First QC Date

November 13, 2024

Last Update Submit

November 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prediction accuracy of postoperative recurrence in locally advanced gastric cancer

    The primary outcome measure is the accuracy of the multimodal AI model in predicting the risk of postoperative recurrence in patients with locally advanced gastric cancer. This is assessed by comparing the model's predictions with actual recurrence events over a specified follow-up period, allowing evaluation of its effectiveness in identifying high-risk patients and guiding clinical decisions.

    24 months postoperative follow-up

Interventions

This intervention involves a multimodal artificial intelligence (AI) model that integrates clinical data, imaging results, and pathology findings to predict the risk of postoperative recurrence in patients with locally advanced gastric cancer. Unlike traditional methods that may rely on single data sources, this AI-driven model synthesizes multiple types of patient information, offering a comprehensive and personalized prediction of recurrence risk. This approach aims to improve accuracy in identifying high-risk patients, allowing for more tailored follow-up and treatment planning to enhance patient outcomes.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population includes adult patients (aged 18 and older) diagnosed with locally advanced gastric cancer (Stage II or III) who have undergone surgical resection. This population is selected based on the availability of complete clinical, imaging, and pathology data necessary for analysis by the multimodal AI-driven predictive model. The study focuses on assessing the postoperative recurrence risk in this specific group to improve personalized follow-up and treatment planning.

You may qualify if:

  • Patients diagnosed with locally advanced gastric cancer (Stage II or III).
  • Patients who have undergone surgical resection for gastric cancer.
  • Patients with complete clinical, imaging, and pathology data available for analysis.
  • Age 18 years or older.
  • Patients who provide informed consent to participate in the study.

You may not qualify if:

  • Patients with distant metastasis (Stage IV) at the time of diagnosis.
  • Patients with incomplete or missing clinical, imaging, or pathology data.
  • Patients who have received prior treatment for gastric cancer other than surgical resection.
  • Patients with other concurrent malignancies.
  • Patients who are unable or unwilling to comply with the study follow-up requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2024

First Posted

November 15, 2024

Study Start

January 1, 2022

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

November 15, 2024

Record last verified: 2024-11

Locations