Machine Learning Model Guided by TLS Predicts Survival and Immune Features in Gastric Cancer

NCT ID: NCT06979817

Last Updated: 2025-05-20

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

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2024-01-01

Brief Summary

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This study aims to develop and validate a machine learning model that uses information from tertiary lymphoid structures (TLSs)-specialized immune-related cell clusters found near tumors-to predict survival outcomes and immune characteristics in patients with locally advanced gastric cancer. By analyzing clinical data, pathology, and imaging results, the model may help doctors better understand a patient's prognosis and personalize treatment strategies. The study will also explore how TLS-related immune patterns relate to the effectiveness of certain therapies, potentially offering new insights for immune-based treatment planning.

Detailed Description

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Conditions

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Locally Advanced Gastric Cancer Tumor Immune Microenvironment Tertiary Lymphoid Structures (TLS)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Locally Advanced Gastric Cancer Patients

TLS-Informed Machine Learning Prognostic Model

Intervention Type OTHER

This intervention involves the development and application of a machine learning-based prognostic model that integrates features derived from tertiary lymphoid structures (TLSs) identified in tumor pathology slides, along with clinical and immunological data, to predict overall survival and immune landscape in patients with locally advanced gastric cancer. The model utilizes digital pathology, image analysis, and advanced computational algorithms to quantify TLS-related characteristics and correlate them with patient outcomes. It is designed to stratify patients into risk groups and provide insight into the tumor immune microenvironment, aiming to support personalized treatment planning.

Interventions

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TLS-Informed Machine Learning Prognostic Model

This intervention involves the development and application of a machine learning-based prognostic model that integrates features derived from tertiary lymphoid structures (TLSs) identified in tumor pathology slides, along with clinical and immunological data, to predict overall survival and immune landscape in patients with locally advanced gastric cancer. The model utilizes digital pathology, image analysis, and advanced computational algorithms to quantify TLS-related characteristics and correlate them with patient outcomes. It is designed to stratify patients into risk groups and provide insight into the tumor immune microenvironment, aiming to support personalized treatment planning.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Histologically confirmed locally advanced gastric adenocarcinoma (clinical stage cT2-T4 and/or N+)

Underwent curative-intent gastrectomy (with or without neoadjuvant therapy)

Availability of adequate tumor tissue specimens for TLS assessment via digital pathology

Complete baseline clinical, pathological, and follow-up data

Age ≥ 18 years

Written informed consent provided (if prospective study component is included)

Exclusion Criteria

Distant metastases at the time of diagnosis or surgery (M1 stage)

Prior history of other malignancies within the past 5 years, except for adequately treated in situ carcinoma or non-melanoma skin cancer

Incomplete or missing essential clinical, pathological, or survival data

Poor-quality tissue samples not suitable for TLS quantification or digital analysis

Participation in another clinical trial that may interfere with the study outcomes
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qun Zhao

OTHER

Sponsor Role lead

Responsible Party

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Qun Zhao

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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GC-RAD-AI-2025-03

Identifier Type: -

Identifier Source: org_study_id

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