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Observational Study of Kidney Transplant Diagnostics

This observational study is looking at a new way to diagnose problems in kidney transplants. Currently, doctors use the Banff Classification, which is based on agreement among experts. However, this study aims to improve diagnosis by using a new system that combines information from molecular tests (looking at genes and cells), tissue samples (histopathology), and other patient information. The goal is to create a more accurate way to understand why a kidney transplant might not be working well. You may be able to join if you are 18 or older and are having a kidney biopsy because your doctor thinks there might be a problem with your transplanted kidney. The study will be successful if this new diagnostic system is proven to work well. The study has already collected information from over 2,300 participants.

Study design
This is an observational study aiming to enroll 500 participants, though it has already collected data from over 2,300. It is not testing a specific treatment, but rather a new diagnostic system.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Follow-up data is, and will be, collected. The primary endpoint is measured between 2013 and 2016.

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NCT01299168

Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

Recruiting
Not specifiedAges 18+Observational
University of Alberta
~500 participants
Updated 2026-06-02 on ClinicalTrials.gov

At a glance

Recruiting sites
3 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Validate the Integrated Diagnostic System in the International Collaborative Microarray (INTERCOM) Study
Measured over 2013-2016

Conditions

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

Explore related trials

Kidney Transplantation

Where it's being run

26 sites across 24 states
France2
Germany2
Alabama1
Maryland1
Michigan1
Minnesota1
Missouri1
New York1

Study leadership

  • Philip F Halloran, MD PhD · PRINCIPAL_INVESTIGATOR · University of Alberta

Who to contact

Philip F Halloran, MD PhD
[email protected]
1 780 492-6160
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Eligibility criteria

Inclusion

All kidney transplant recipients ≥18yrs of age undergoing a kidney biopsy for clinical indications, as determined by their physician or surgeon, will be eligible to enrol in the study.

Exclusion

Patients will be excluded from the study if they decline participation or are unable to give informed consent.

What this trial measures

  • Validate the Integrated Diagnostic System in the International Collaborative Microarray (INTERCOM) Study2013-2016

    1. The rejection classifier predicts Banff diagnosis of any rejection: ABMR, TCMR, or mixed ABMR and TCMR; 2. The TCMR classifier predicts the presence of Banff TCMR lesions/diagnoses; 3. The ABMR classifier predicts the presence of ABMR lesions; 4. In late (\>1yr) biopsies for clinical indications, the failure classifier predicts failure within three years.