NCT07092397

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

2.5 years

First QC Date

July 13, 2025

Last Update Submit

July 22, 2025

Conditions

Gallbladder Cancer

Keywords

gallbladder cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    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 (1)

  • Disease-free survival

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with gallbladder cancer who underwent curative-intent surgery with R0 resection at Samsung Medical Center between 2010 and 2020 formed the main study cohort. An external validation cohort included patients with gallbladder cancer at Asan Medical Center between 2017 and 2022 with available archived hematoxylin and eosin-stained slides for AI-powered tumor microenvironment analysis. Patients with inadequate tissue samples were excluded.

You may qualify if:

  • Patients who underwent curative surgery for gallbladder cancer.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Gallbladder Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2025

First Posted

July 29, 2025

Study Start

April 5, 2022

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

July 29, 2025

Record last verified: 2025-07

Locations

KR(1)