Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

June 1, 2026 updated by: Philip Halloran, University of Alberta

Multi-centric Observational Study to Analyse the Diagnostic Molecular Features in the Clinical Setting of Kidney Allograft Biopsies

The current standard for biopsy-based diagnoses of dysfunction of kidney transplants is the Banff Classification which represents arbitrary international consensus. Recent data-driven approaches using molecular and conventional technologies indicate that mere consensus produces frequently incorrect diagnoses with potential harm to patients due to inappropriate treatment. To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC) has developed a new diagnostic system that combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic System. The present study will validate and refine this system in 500 prospectively unselected biopsies for clinical indications from American, Canadian and European centres in addition to 300 biopsies already collected. Due to a considerable interest and support from participating Centers, the study is further extended to 1500 prospective biopsies. Thus this is the extension of the INTERCOM study (INTERCOMEX). In addition to demonstrating the feasibility and value of this System in routine patient care and clinical trials, the study will develop and optimize a transparent and user-friendly reporting format to communicate this information to clinicians and obtain detailed feedback on how this system can best improve patient care.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The study has enrolled so far 3012 biopsies from 2313 participants and the results are analyzed for these biopsies. Follow-up data is, and will be collected.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2S2
        • Recruiting
        • Department of Medicine, University of Alberta
        • Contact:
        • Principal Investigator:
          • Soroush Shojai, MD
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Withdrawn
        • University of British Columbia, St. Paul's Hospital
  • Croatia
      • Zagreb, Croatia
        • Completed
        • University Hospital Merkur
  • Czechia
      • Prague, Czechia
        • Recruiting
        • Institute for Experimental and Clinical Medicine (IKEM)
        • Contact:
        • Principal Investigator:
          • Ondrej Viklicky, Dr
  • France
      • Paris, France
        • Completed
        • Hopital Necker
      • Paris, France
        • Completed
        • Hopital St. Louis
  • Germany
      • Berlin, Germany
        • Completed
        • Charité - Universitätmedizin Berlin
      • Hanover, Germany, 30625
        • Completed
        • Medizinische Hochschule
  • Ireland
      • Dublin, Ireland
        • Withdrawn
        • Beaumont Hospital
  • Poland
      • Szczecin, Poland
        • Completed
        • Pomeranian Medical University in Szczecin
  • Slovenia
      • Ljubljana, Slovenia
        • Completed
        • University of Ljubljana
  • South Korea
      • Seoul, South Korea, 05505
        • Completed
        • Department of Surgery, University of Usan, College of Medicine
  • Spain
      • Barcelona, Spain, 08035
        • Completed
        • Vall d'Hebron Hospital
  • Switzerland
      • Zurich, Switzerland, 8091
        • Completed
        • University Hospital Zurich
  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Completed
        • Manchester Royal Infirmary
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0006
        • Completed
        • University of Alabama
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Completed
        • University of Maryland School of Medicine
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5395
        • Completed
        • University of Michigan Health System
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Completed
        • University of Minnesota
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Completed
        • Barnes-Jewish Hospital
    • New York
      • The Bronx, New York, United States
        • Completed
        • Montefiore Medical Center
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States
        • Completed
        • Pinnacle Transplant Associates
    • Texas
      • San Antonio, Texas, United States, 78229
        • Completed
        • Texas Transplant Institute - Methodist Healthcare System
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Completed
        • Virginia Commonwealth University School of Medicine
    • Wisconsin
      • Madison, Wisconsin, United States, WI 53705
        • Completed
        • University of Wisconsin School of Medicine and Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population includes patients with a functioning kidney transplant undergoing a biopsy for clinicalindications as standard of care to determine the cause of their graft dysfunction (deterioration in graft function, delayed graft function, proteinuria).

Description

Inclusion Criteria:

  • 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 Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Kidney Transplant Biopsies for Cause
The study population includes patients with a functioning kidney transplant undergoing a biopsy for clinical indications as standard of care to determine the cause of their graft dysfunction (deterioration in graft function, delayed graft function, proteinuria).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validate the Integrated Diagnostic System in the International Collaborative Microarray (INTERCOM) Study
Time Frame: 2013-2016
  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.
2013-2016

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate the feasibility of molecular phenotyping of 300 + 500 kidney transplant biopsies for clinical indications.
Time Frame: 2014-2016
To test the hypothesis that the molecular phenotype of a newly acquired sample predicts the histologic and clinical features of this sample.
2014-2016
Demonstrate the feasibility of molecular phenotyping of 500 biopsies in real time i.e. returning the molecular phenotyping report in two working days upon sample arrival.
Time Frame: 2015-2016
Refine the reports based on feedback from the participants.
2015-2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Philip F Halloran, MD PhD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimated)

February 18, 2011

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATAGC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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