Kidney TransplantationNCT07004660
Performances of Large Language Models in Kidney Allograft Diagnostics
An observational study of Kidney Transplantation, run by Paris Translational Research Center for Organ Transplantation.
Trial summary
Kidney allograft rejection diagnosis relies on the complex Banff classification, but its application is limited by variability and workload. Our group previously built a scripted automation system, though it required major expert input. Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- Kidney Transplantation
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2004to 31 Dec 2023
- 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 0 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Kidney recipients
Who may be able to join
- Kidney recipients
Who cannot join
- Combined transplant
About this study
Kidney allograft rejection diagnosis relies on the complex Banff classification, but its application is limited by variability and workload. Our group previously built a scripted automation system, though it required major expert input. This study assesses whether modern LLMs can achieve similar diagnostic performance using Banff-based prompts, without extensive manual engineering.
Read the detailed description
Kidney allograft rejection remains a leading cause of allograft failure. Histological diagnosis relies on the Banff classification, a complex and evolving rule based framework. While successive Banff working groups refined the guidelines over time, daily interpretation is still hampered by inter and intra pathologist variability and growing demands on renal pathologists. This is why our group previously built a fully scripted Banff automation system. However, this system demanded years of expert curation and bespoke code before reaching acceptable accuracy. Whether modern LLMs, which show high capabilities to generate consistent and transparent reasoning at scale, can match expert pathologists without such resource intensive engineering remains unknown. The present study was therefore designed to benchmark state of the art LLMs against consensus diagnoses from senior renal pathologists on a representative series of kidney allograft biopsies, and to explore whether properly engineered prompts can translate Banff rules into reliable, reproducible diagnostic output.
- Conditions
- Kidney Transplantation
- Keywords
- Large language model, Banff classification, Diagnosis, Kidney transplantation, Biopsy
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Necker hospital | Transplant unit from Necker hospital, France | |
| Saint-Louis hospital | Transplant unit from Saint-Louis hospital, France |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy diagnosis
The diagnosis of the biopsy will be based on the latest Banff classification (2022). The diagnoses will include i) biopsies with nonspecific lesions or clean (n=40), ii) biopsies with antibody-mediated rejection (AMR) (n=40) among which 14 had acute AMR, 13 chronic active AMR and 13 chronic inactive AMR, iii) biopsies with T cell-mediated rejection (TCMR) (n=40), among which 20 had acute TCMR and 20 had chronic active TCMR, iv) biopsies with borderline for acute TCMR (n=40), v) biopsies with mixed rejection (n=40), and vi) biopsies with microvascular inflammation (MVI) (n=40) among which 20 had probable AMR and 20 had MVI without DSA and without C4d.
Measured: The biopsy will be protocol biopsies performed at 3 months and 1 year post transplant, or for-cause biopsies performed at any time post transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Mar 2004
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paris Translational Research Center for Organ Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Raynaud, Paris Translational Research Center for Organ Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004660
- Sponsor's protocol ID
- LLM_vs_Patho_001
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performances of Large Language Models in Kidney Allograft Diagnostics
- ClinicalTrials.gov ID
- NCT07004660
- Acronym / sponsor ID
- LLM_vs_Patho_001
- Conditions
- Kidney Transplantation
- Keywords
- Large language model, Banff classification, Diagnosis, Kidney transplantation, Biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Paris Translational Research Center for Organ TransplantationUniversity, hospital or other
- Study start
- 1 Mar 2004 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 4 Jun 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.
Kidney allograft rejection diagnosis relies on the complex Banff classification, but its application is limited by variability and workload. Our group previously built a scripted automation system, though it required major expert input. This study assesses whether modern LLMs can achieve similar diagnostic performance using Banff-based prompts, without extensive manual engineering.
Detailed description
Kidney allograft rejection remains a leading cause of allograft failure. Histological diagnosis relies on the Banff classification, a complex and evolving rule based framework. While successive Banff working groups refined the guidelines over time, daily interpretation is still hampered by inter and intra pathologist variability and growing demands on renal pathologists. This is why our group previously built a fully scripted Banff automation system. However, this system demanded years of expert curation and bespoke code before reaching acceptable accuracy. Whether modern LLMs, which show high capabilities to generate consistent and transparent reasoning at scale, can match expert pathologists without such resource intensive engineering remains unknown. The present study was therefore designed to benchmark state of the art LLMs against consensus diagnoses from senior renal pathologists on a representative series of kidney allograft biopsies, and to explore whether properly engineered prompts can translate Banff rules into reliable, reproducible diagnostic output.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Necker hospital | – | –Transplant unit from Necker hospital, France |
| Saint-Louis hospital | – | –Transplant unit from Saint-Louis hospital, France |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Kidney recipients
Key inclusion criteria (1 listed)
- Kidney recipients
Key exclusion criteria (1 listed)
- Combined transplant
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
Biopsy diagnosis
Time frame: The biopsy will be protocol biopsies performed at 3 months and 1 year post transplant, or for-cause biopsies performed at any time post transplant.
The diagnosis of the biopsy will be based on the latest Banff classification (2022). The diagnoses will include i) biopsies with nonspecific lesions or clean (n=40), ii) biopsies with antibody-mediated rejection (AMR) (n=40) among which 14 had acute AMR, 13 chronic active AMR and 13 chronic inactive AMR, iii) biopsies with T cell-mediated rejection (TCMR) (n=40), among which 20 had acute TCMR and 20 had chronic active TCMR, iv) biopsies with borderline for acute TCMR (n=40), v) biopsies with mixed rejection (n=40), and vi) biopsies with microvascular inflammation (MVI) (n=40) among which 20 had probable AMR and 20 had MVI without DSA and without C4d.
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 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by Paris Translational Research Center for Organ Transplantation.
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: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Biopsy diagnosis (time frame: The biopsy will be protocol biopsies performed at 3 months and 1 year post transplant, or for-cause biopsies performed at any time post transplant.). 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 4 Jun 2025.