Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

Recruiting

• Conditions: Validation Study of Molecular Diagnostic System; Development of Reporting System for Molecular Diagnosis; Incorporate Molecular Diagnosis Into Diagnostic Standards

• Registration Number: NCT01299168
• Lead Sponsor: University of Alberta

Brief Summary

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.

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 Timeline

• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-18
• Study Start: 2011-05-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-17
• Primary Completion: 2025-12
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validate the Integrated Diagnostic System in the International Collaborative Microarray (INTERCOM) Study	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.

Secondary Outcome Measures

Name	Time	Method
Demonstrate the feasibility of molecular phenotyping of 300 + 500 kidney transplant biopsies for clinical indications.	2014-2016	To test the hypothesis that the molecular phenotype of a newly acquired sample predicts the histologic and clinical features of this sample.
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.	2015-2016	Refine the reports based on feedback from the participants.

Trial Locations

Locations (26)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

Pinnacle Transplant Associates; 🇺🇸 Harrisburg, Pennsylvania, United States

Texas Transplant Institute - Methodist Healthcare System; 🇺🇸 San Antonio, Texas, United States

Virginia Commonwealth University School of Medicine; 🇺🇸 Richmond, Virginia, United States

University of Wisconsin School of Medicine and Public Health; 🇺🇸 Madison, Wisconsin, United States

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