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

Q

Qun Zhao

Status

Completed

Conditions

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

Treatments

Other: TLS-Informed Machine Learning Prognostic Model

Study type

Observational

Funder types

Other

Identifiers

NCT06979817
GC-RAD-AI-2025-03

Details and patient eligibility

About

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.

Enrollment

1,200 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

1,200 participants in 1 patient group

Locally Advanced Gastric Cancer Patients
Treatment:
Other: TLS-Informed Machine Learning Prognostic Model

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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