Gallbladder CancerNCT07092397
Artificial Intelligence-based Tumor Microenvironment Analysis for Prognosis Prediction in Gallbladder Cancer
An observational study of Gallbladder Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gallbladder Cancer
- How many people
- 266 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Apr 2022to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients who underwent curative surgery for gallbladder cancer.
Who cannot join
- Patients who did not achieve R0 resection.
- Patients with metastatic disease.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Gallbladder Cancer
- Keywords
- gallbladder cancer
- Medical subject headings
- Gallbladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 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
Measured: From date of surgery to the date of disease recurrence, assessed up to 165 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start5 Apr 2022
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JooKyung Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092397
- Sponsor's protocol ID
- SMC-2022-03-136
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is no current plan to publicly share individual participant data (IPD). However, de-identified data may be shared upon reasonable request, subject to approval by the institutional review board and compliance with data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-based Tumor Microenvironment Analysis for Prognosis Prediction in Gallbladder Cancer
- ClinicalTrials.gov ID
- NCT07092397
- Acronym / sponsor ID
- SMC-2022-03-136
- Conditions
- Gallbladder Cancer
- Keywords
- gallbladder cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients who underwent curative surgery for gallbladder cancer.
Key exclusion criteria (2 listed)
- Patients who did not achieve R0 resection.
- Patients with metastatic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Disease-free survival
Time frame: From date of surgery to the date of disease recurrence, assessed up to 165 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: Undecided. There is no current plan to publicly share individual participant data (IPD). However, de-identified data may be shared upon reasonable request, subject to approval by the institutional review board and compliance with data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallbladder Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.