Artificial Intelligence-based Tumor Microenvironment Analysis for Prognosis Prediction in Gallbladder Cancer

This retrospective study aims to investigate the prognostic significance of artificial intelligence (AI)-powered analysis of tumor-infiltrating lymphocytes (TILs) and the tumor microenvironment (TME) in patients with resected gallbladder cancer. Using hematoxylin and eosin (H&E)-stained slides, the study quantifies spatial TME features, including TIL density, tertiary lymphoid structures, and fibroblast density, to identify potential TME-related risk factors associated with survival.

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Key information

Conditions

Gallbladder Cancer Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Gallbladder Diseases Gallbladder Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who underwent curative surgery for gallbladder cancer.

Exclusion criteria

Patients who did not achieve R0 resection.
Patients with metastatic disease.

Treatment and study plan

Primary outcomes

Overall survival

Time frame: From date of surgery (or diagnosis) to the date of death from any cause or the last follow-up, assessed up to 165 months

Secondary outcomes

Disease-free survival

Time frame: From date of surgery to the date of disease recurrence, assessed up to 165 months

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Jul 29, 2025
Registry last updated: Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed