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

TLS-Informed Machine Learning Model Predicts Survival and Immune Landscape in Locally Advanced Gastric Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06979817
Enrollment
1200
Registered
2025-05-20
Start date
2012-01-01
Completion date
2024-01-01
Last updated
2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

OTHERTLS-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.

Sponsors

Qun Zhao
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frame
Overall Survival Predicted by TLS-Informed Machine Learning ModelUp to 5 Years Post-Surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026