Development and Validation of a Virtual Biopsy System in Kidney Transplant

NCT04759209 | Unknown

• 1 other identifier: VirtualBx/KT
• Study Type: observational
• Target: 12,992
• Locations: 1 country
• Sites: 1

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).

Conditions

Kidney Transplantation

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Biopsies DIAGNOSTIC_TEST

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Paris Transplant Group

Paris, 75015, France

Location

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Alexandre Loupy

  Paris Translational Research Center for Organ Transplantation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 18, 2021
• Study Start: January 1, 2000
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)