Performances of Large Language Models in Kidney Allograft Diagnostics

NCT07004660 | Completed DMC

• 1 other identifier: LLM_vs_Patho_001
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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. This study assesses whether modern LLMs can achieve similar diagnostic performance using Banff-based prompts, without extensive manual engineering.

Conditions

Kidney Transplantation

Keywords

Large language model; Banff classification; Diagnosis; Kidney transplantation; Biopsy

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (2)

Necker hospital

Transplant unit from Necker hospital, France

Saint-Louis hospital

Transplant unit from Saint-Louis hospital, France

Eligibility Criteria

• Age: 0 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney recipients

You may qualify if:

• Kidney recipients

You may not qualify if:

• Combined transplant

Sponsors & Collaborators

• Paris Translational Research Center for Organ Transplantation: lead

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 4, 2025
• Study Start: March 1, 2004
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 4, 2025

Record last verified: 2025-05