Development and Validation of a Virtual Biopsy System in Kidney Transplant

Development and Validation of a Machine Learning Based Virtual Biopsy System in Kidney Transplant Patients

Currently, kidney allograft biopsies are routinely performed to determine diagnosis and prognosis of kidney allografts. The histological interpretation of these biopsies is based on the Banff consensus for renal allograft pathology. The purpose of this study is to provide to the physicians a reliable estimation of renal allograft lesions of the day zero biopsy (kidney donor biopsy performed before transplantation).

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Transplantation
• Intervention / Treatment: Diagnostic test: Biopsies

Detailed Description

In kidney transplantation, day-zero biopsies are essential to assess organ quality and discriminate the donor transmitted or acquired lesions and disease progression post-transplant. However, many centers worldwide do not perform those biopsies because they are invasive and costly. We aimed to develop and validate a non-invasive virtual biopsy system. Our goal was to provide clinicians with a virtual biopsy system to guide diagnostics, therapeutics and immediate patient management post-transplant and to minimize additional risks and costs to perform day-zero biopsies only using standard donor parameters. To circumvent these limitations, we sought to build and validate a virtual biopsy system that uses routinely collected donor parameters to predict kidney day-zero biopsy results. Since machine learning has demonstrated its clinical relevance in many medical specialties and superior performance to logistic regression, we based our analyses on machine learning methods as well as traditional statistical approaches using large and qualified international cohort donors who underwent routine and protocolized collection of donor parameters together with day-zero biopsy assessment using the standards of the international Banff allograft histopathology classification.

• Study Type: Observational
• Enrollment (Actual): 12992

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Paris Transplant Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Living or deceased kidney donors who underwent a kidney biopsy performed prior to kidney transplantation.

Description

Inclusion Criteria:

- Kidney donors who underwent kidney biopsies performed prior to kidney transplantation, aged at least 18 years old.

Exclusion Criteria:

• inadequate biopsies according to Banff international classification (number of glomeruli less than 10),
• biopsies with two or more Banff scores of interest missing.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arteriosclerosis score according to Banff International Classification	Arteriosclerosis defined by arterial intimal thickening in the most severely affected artery (Banff "cv" score)	up to 1 day post-transplant
Arteriolar Hyalinosis score according to Banff International Classification	arteriolar hyalinosis defined by periodic acid-Schiff (PAS)-positive arteriolar hyaline thickening (Banff "ah" score),	up to 1 day post-transplant
Interstitial fibrosis and tubular atrophy score according to Banff International Classification	interstitial fibrosis and tubular atrophy computed with the extent of cortical fibrosis (Banff "ci" score) and cortical tubular atrophy (Banff "ct" score).	up to 1 day post-transplant
Continuous percentage of sclerotic glomeruli	continuous percentage of sclerotic glomeruli is defined by the percentage of the total number of glomeruli affected by global sclerosis	up to 1 day post-transplant

Collaborators and Investigators

• Sponsor: Paris Translational Research Center for Organ Transplantation
• Collaborators: Assistance Publique - Hôpitaux de Paris; Mayo Clinic; University of British Columbia; KU Leuven; Hospital Clinic of Barcelona; University of Alberta; University of Liege; Clinical Hospital Centre Zagreb; University of Adelaide; Hospital Universitari de Bellvitge; Hospital Vall d'Hebron

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2000
• Primary Completion (Actual): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Kidney transplantation; Day-zero biopsy; Machine learning; Non-invasive biopsy; Common parameters
• Other Study ID Numbers: VirtualBx/KT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No