Liver CirrhosisNCT07885007
AI-SC Multi-center Study
An observational study of Liver Cirrhosis, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
To examined the opportunity for Artificial Intelligence (AI) agents to evaluate transplant candidacy objectively at LT-SC, with a large language models (LLM) representing the expertise of each individual specialist (hepatologist, surgeon, anesthesiologist, psychiatrist and social worker) and coming up with a group… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- evaluate the alignment between AI-SC recommendations and LT-SC decisions and Multi AI-SC model
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient with liver cirrhosis on evaluation for liver transplant
Who may be able to join
- patient more or equal to 18 years of age with liver cirrhosis on assessment for liver transplant
Who cannot join
- multi-organ transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Multi-Agent AI Selection Committee for Objective Assessment of Liver Transplant Candidacy
To examined the opportunity for Artificial Intelligence (AI) agents to evaluate transplant candidacy objectively at LT-SC, with a large language models (LLM) representing the expertise of each individual specialist (hepatologist, surgeon, anesthesiologist, psychiatrist and social worker) and coming up with a group consensus decision upon inter-agent communication using prompts GPT-4 in OpenAI (private version).
Read the detailed description
The study seeks to evaluate the feasibility and acceptability of integrating such AI agents into LT candidate assessments with a retrospective evaluation and validation of a multi-disciplinary selection committee of AI agents (AI-SC) at major transplant centers, including MeDanTa (India), King Saud bin Abdulaziz University (Saudi Arabia), King Abdullah International Medical Research Center (Saudi Arabia), National University Hospital (Singapore), UCSF Health (US), Vanderbilt University Medical Center (US), John Hopkins Hospital (US), Mayo Clinic (US), Royal Prince Alfred Hospital (AU), and University Health Network (UHN-CA).
- Conditions
- Liver Cirrhosis
- Being tested
- evaluate the alignment between AI-SC recommendations and LT-SC decisions, Multi AI-SC model
- Keywords
- AI-SC Agent Multicenter
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluate the alignment between AI-SC recommendations and LT-SC decisionsOther
To validate the developed model, investigators invited other collaborating centers, including Vancouver Coastal Health (Canada), Mayo Clinic (US), John Hopkins Hospital (US), Royal Prince Alfred Hospital (AU), National University of Singapore (Singapore), UCSF Health (US), Vanderbilt University Medical Center (US), John Hopkins Hospital (US), MeDanTa (India), and Ministry of National Guard Health Affairs (Saudi Arabia) to perform a validation as an extension of data governance phase.
Multi AI-SC modelOther
To evaluate the feasibility and acceptability of integrating such multi AI-SC(Selection Committee) agents into LT candidate assessments.
| Study group | Role | What they receive |
|---|---|---|
| AI-SC | AI - Selection Committee Receives: Other: evaluate the alignment between AI-SC recommendations and LT-SC decisions; Other: Multi AI-SC model | |
| Human Liver transplant (LT)-SC | Human Liver Transplant Selection Committee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of AI-SC vs LT-SC review
- Our primary outcome will be any substantial change in the content, method, or result of the patient assessment between the AI-SC and conventional reports. Investigators will calculate the percentage of concordance between the two, and the similarity of report generated by the human and the AI-SC will be evaluated using ROUGE score (Recall-Oriented Understudy for Gisting Evaluation), a quantitative metric that assesses textual similarity3.
Measured: 3 months
Concordance between AI-SC vs LT-SC
Our primary outcome will be any substantial change in the content, method, or result of the patient assessment between the AI-SC and conventional reports. Investigators will calculate the percentage of concordance between the two, and the similarity of report generated by the human and the AI-SC will be evaluated using ROUGE score (Recall-Oriented Understudy for Gisting Evaluation), a quantitative metric that assesses textual similarity3
Measured: 3 months
Secondary outcomes (1)
Time of adjudication
- The secondary outcomes will be the safety of assessments in cases where substantial changes are made, time required for adjudications, frequency of decision changes between AI-SC and conventional LT-SC. Investigators will also evaluate the consistency of the decision making across controversial variables, such as age, cardiovascular health, and frailty over time, to evaluate whether AI-SC can provide more objectivity in the decision-making.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo University Hospital, University of California, San Francisco, Vanderbilt University Medical Center, Johns Hopkins University, Medanta, The Medicity, India, Royal Prince Alfred Hospital, Sydney, Australia, National University Hospital, Singapore, King Saud Bin Abdulaziz University for Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885007
- Sponsor's protocol ID
- 25-5945
- Status last verified
- May 2026
- First submitted
- 13 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Multi-Agent AI Selection Committee for Objective Assessment of Liver Transplant Candidacy
- ClinicalTrials.gov ID
- NCT07885007
- Acronym / sponsor ID
- 25-5945
- Conditions
- Liver Cirrhosis
- Keywords
- AI-SC Agent Multicenter
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Mayo University Hospital, University of California, San Francisco, Vanderbilt University Medical Center, Johns Hopkins University, Medanta, The Medicity, India, Royal Prince Alfred Hospital, Sydney, Australia, National University Hospital, Singapore, King Saud Bin Abdulaziz University for Health Sciences
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Oct 2026 (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.
To examined the opportunity for Artificial Intelligence (AI) agents to evaluate transplant candidacy objectively at LT-SC, with a large language models (LLM) representing the expertise of each individual specialist (hepatologist, surgeon, anesthesiologist, psychiatrist and social worker) and coming up with a group consensus decision upon inter-agent communication using prompts GPT-4 in OpenAI (private version).
Detailed description
The study seeks to evaluate the feasibility and acceptability of integrating such AI agents into LT candidate assessments with a retrospective evaluation and validation of a multi-disciplinary selection committee of AI agents (AI-SC) at major transplant centers, including MeDanTa (India), King Saud bin Abdulaziz University (Saudi Arabia), King Abdullah International Medical Research Center (Saudi Arabia), National University Hospital (Singapore), UCSF Health (US), Vanderbilt University Medical Center (US), John Hopkins Hospital (US), Mayo Clinic (US), Royal Prince Alfred Hospital (AU), and University Health Network (UHN-CA).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-SC | – | Other: evaluate the alignment between AI-SC recommendations and LT-SC decisions, Other: Multi AI-SC modelAI - Selection Committee |
| Human Liver transplant (LT)-SC | – | –Human Liver Transplant Selection Committee |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with liver cirrhosis on evaluation for liver transplant
Key inclusion criteria (1 listed)
- patient more or equal to 18 years of age with liver cirrhosis on assessment for liver transplant
Key exclusion criteria (1 listed)
- multi-organ transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluate the alignment between AI-SC recommendations and LT-SC decisionsTo validate the developed model, investigators invited other collaborating centers, including Vancouver Coastal Health (Canada), Mayo Clinic (US), John Hopkins Hospital (US), Royal Prince Alfred Hospital (AU), National University of Singapore (Singapore), UCSF Health (US), Vanderbilt University Medical Center (US), John Hopkins Hospital (US), MeDanTa (India), and Ministry of National Guard Health Affairs (Saudi Arabia) to perform a validation as an extension of data governance phase. | Other | AI-SC |
| Multi AI-SC modelTo evaluate the feasibility and acceptability of integrating such multi AI-SC(Selection Committee) agents into LT candidate assessments. | Other | AI-SC |
Primary outcome
Concordance of AI-SC vs LT-SC review
Time frame: 3 months
· Our primary outcome will be any substantial change in the content, method, or result of the patient assessment between the AI-SC and conventional reports. Investigators will calculate the percentage of concordance between the two, and the similarity of report generated by the human and the AI-SC will be evaluated using ROUGE score (Recall-Oriented Understudy for Gisting Evaluation), a quantitative metric that assesses textual similarity3.
Concordance between AI-SC vs LT-SC
Time frame: 3 months
Our primary outcome will be any substantial change in the content, method, or result of the patient assessment between the AI-SC and conventional reports. Investigators will calculate the percentage of concordance between the two, and the similarity of report generated by the human and the AI-SC will be evaluated using ROUGE score (Recall-Oriented Understudy for Gisting Evaluation), a quantitative metric that assesses textual similarity3
1 secondary outcome
Time of adjudication
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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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 Liver Cirrhosis, run by University Health Network, Toronto at 1 site in Canada.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Concordance of AI-SC vs LT-SC review (time frame: 3 months). The study lists 2 primary outcomes in all. 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 26 Oct 2026.