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NCT06979817Completed

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

Source: ClinicalTrials.gov · Last updated 20 May 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
1200 (actual)
First submitted
12 May 2025
Start date
1 Jan 2012
Primary completion date
1 Jan 2024
Lead sponsor
Qun Zhao
NCT number
NCT06979817

What you commit to

  • Study type: Observational
  • Participants enrolled: 1200
  • From 1 Jan 2012 to the primary completion date, 1 Jan 2024
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

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

Other

  • 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

Who the study is looking for

  • 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)

Age in the registry: 18 years to 80 years · Sex: All

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.