Development and Validation of a Virtual Biopsy System in Kidney Transplant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

12992 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

AI for Allograft Diseases Diagnosis and Prognosis After Kidney Transplantation

NCT05112770

Kidney Transplantation

WITHDRAWN

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

NCT05306795

Kidney Transplant Rejection Pathology

UNKNOWN

Pathology and Imaging in Kidney Allografts

NCT03780101

Renal Transplant Rejection Chronic Kidney Diseases Fibrosis

TERMINATED

Impact of Microvascular Inflammation on Kidney Allograft Outcome

NCT06496269

Transplant;Failure,Kidney Kidney Transplant Rejection

COMPLETED

Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

NCT01299168

Validation Study of Molecular Diagnostic System Development of Reporting System for Molecular Diagnosis Incorporate Molecular Diagnosis Into Diagnostic Standards

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biopsies

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No