Development and Validation of a Virtual Biopsy System in Kidney Transplant

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04759209
• Other study ID #: VirtualBx/KT
• Status: Active, not recruiting
• Start date: January 1, 2000
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: Paris Translational Research Center for Organ Transplantation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12992
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Diagnostic Test:
• Biopsies

Locations

Country	Name	City	State
France	Paris Transplant Group	Paris

Sponsors (12)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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