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临床试验/NCT07004660
NCT07004660已完成不适用

Performances of Large Language Models in Kidney Allograft Diagnostics

Paris Translational Research Center for Organ Transplantation0 个研究点目标入组 240 人开始时间: 2004年3月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
240
主要终点
Biopsy diagnosis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Kidney recipients

排除标准

  • Combined transplant

结局指标

主要结局

Biopsy diagnosis

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Paris Translational Research Center for Organ Transplantation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Raynaud

PhD

Paris Translational Research Center for Organ Transplantation

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