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Development and Validation of a Comprehensive Classification Automation System for Kidney Allograft Biopsies

NCT05306795 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2022-04-11

No results posted yet for this study

Summary

Since 1991, the Banff classification has been the gold standard for defining antibody-mediated rejection (AMR) and T-cell mediated rejection (TCMR), thereby guiding the treatment and management of transplant recipients. Starting from a pure histological approach, the classification has moved over the past three decades towards an integrated precision diagnosis system, which encompasses other expertise, such as immunology, immunogenetic, other basic sciences, biostatistics, data science, and artificial intelligence The counterpart of this constant refinement is that Banff rules are becoming complex to follow, with numerous possible scenarios leading to a high degree of inter-observer variability and misclassifications, which may lead to therapeutic consequences.

The aims of this study are:

1. To integrate and decode all Banff rules and develop a computer-based application - the Banff Automation System - which provides automated and reproducible diagnoses
2. To validate the ability of the Banff Automation System to reclassify rejection diagnoses in multicenter cohort studies and clinical trials.

Conditions

  • Kidney Transplant Rejection
  • Pathology

Sponsors & Collaborators

  • Paris Translational Research Center for Organ Transplantation

    lead OTHER

Principal Investigators

  • Alexandre Loupy, MD, PhD · Paris Translational Centre for Organ Transplantation

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2022-06-01
Completion
2022-12-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05306795 on ClinicalTrials.gov