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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04759209
Enrollment
12992
Registered
2021-02-18
Start date
2000-01-01
Completion date
2021-12-31
Last updated
2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Kidney transplantation, Day-zero biopsy, Machine learning, Non-invasive biopsy, Common parameters

Brief 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).

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.

Interventions

DIAGNOSTIC_TESTBiopsies

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Arteriosclerosis score according to Banff International Classificationup to 1 day post-transplantArteriosclerosis defined by arterial intimal thickening in the most severely affected artery (Banff cv score)
Arteriolar Hyalinosis score according to Banff International Classificationup to 1 day post-transplantarteriolar hyalinosis defined by periodic acid-Schiff (PAS)-positive arteriolar hyaline thickening (Banff ah score),
Interstitial fibrosis and tubular atrophy score according to Banff International Classificationup to 1 day post-transplantinterstitial fibrosis and tubular atrophy computed with the extent of cortical fibrosis (Banff ci score) and cortical tubular atrophy (Banff ct score).
Continuous percentage of sclerotic glomeruliup to 1 day post-transplantcontinuous percentage of sclerotic glomeruli is defined by the percentage of the total number of glomeruli affected by global sclerosis

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026