NCT06534814

Brief Summary

The clinical trial titled "Development and Application of an Artificial Intelligence-Driven Accurate Identification Model for Gastric Cancer Lymph Node Metastasis" aims to enhance the detection and treatment of gastric cancer through the utilization of cutting-edge artificial intelligence (AI) technology. This study will develop an AI-driven model designed to accurately identify lymph node metastasis in patients with gastric cancer, which is crucial for staging the disease and planning effective treatment strategies. The trial will involve a multidisciplinary team of oncologists, radiologists, data scientists, and AI experts who will collaborate to create a robust and precise identification system. Participants will undergo standard diagnostic procedures, and the AI model will analyze imaging and pathological data to predict lymph node involvement. By comparing the AI model's predictions with traditional diagnostic methods, the study seeks to validate the model's accuracy and efficiency. This approach is expected to improve early detection rates, reduce diagnostic errors, and ultimately lead to better clinical outcomes for patients with gastric cancer. The successful implementation of this AI-driven model could revolutionize the current standards of care and serve as a blueprint for integrating AI technologies in other cancer diagnoses and treatments.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
47mo left

Started Jul 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress37%
Jul 2024Jul 2030

Study Start

First participant enrolled

July 1, 2024

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2030

Expected
Last Updated

August 2, 2024

Status Verified

August 1, 2024

Enrollment Period

1.5 years

First QC Date

July 25, 2024

Last Update Submit

August 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Identification of metastatic lymph nodes

    A prediction model based on artificial intelligence technology was constructed to accurately identify metastatic perigastric lymph nodes before surgery.

    2025-12-31

Interventions

The AI-Driven Identification Model for Gastric Cancer Lymph Node Metastasis (AID-GLNM) intervention involves the development and application of an advanced artificial intelligence (AI) system specifically designed to enhance the identification and characterization of lymph node metastasis in patients diagnosed with gastric cancer.

Eligibility Criteria

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

The study population for the clinical trial titled "Development and Application of an Artificial Intelligence-Driven Accurate Identification Model for Gastric Cancer Lymph Node Metastasis (AID-GLNM)" will consist of patients diagnosed with gastric cancer, with a focus on those exhibiting lymph node involvement.

You may qualify if:

  • Diagnosis of Gastric Cancer: Confirmed diagnosis of gastric cancer, either newly diagnosed or recurrent.
  • Lymph Node Involvement: Suspected or confirmed involvement of lymph nodes, as indicated by imaging studies or pathology reports.
  • Age: Patients aged 18 years or older.
  • Performance Status: An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, indicating a functional status that allows participation in the study.
  • Informed Consent: Ability to provide written informed consent to participate in the study.

You may not qualify if:

  • Pregnancy or Lactation: Pregnant or lactating women, due to potential risks to the fetus or infant.
  • Severe Comorbid Conditions: Presence of severe comorbid medical conditions that could interfere with the study or pose additional risks.
  • Previous AI-Driven Diagnostic Intervention: Prior use of any AI-driven diagnostic models specifically for gastric cancer lymph node metastasis.
  • Inability to Comply: Inability or unwillingness to comply with study procedures, including follow-up visits and data collection.
  • Mental or Cognitive Impairment: Conditions that impair the ability to provide informed consent or participate effectively in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General Surgery

Shijiazhuang, Hebei, 050011, China

RECRUITING

Study Design

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

Study Record Dates

First Submitted

July 25, 2024

First Posted

August 2, 2024

Study Start

July 1, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

July 30, 2030

Last Updated

August 2, 2024

Record last verified: 2024-08

Locations