Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:6/1/2018
Start Date:May 2011
End Date:December 2019
Contact:Philip F Halloran, MD PhD
Email:phallora@ualberta.ca
Phone:1 780 492-6160

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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 1200 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.

The study is now enrolling (N=1100) and the results were analyzed for the first 300 collected
biopsies. Follow-up data is, and will be collected.

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.
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San Antonio, Texas
Principal Investigator: . Adam Bingaman, MD
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3550 Jerome Avenue
Bronx, New York 10467
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750 Highland Avenue
Madison, Wisconsin 53792
Principal Investigator: Arjang Djamali, MD, MS
Phone: 608-263-0383
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Minneapolis, Minnesota 55455
(612) 625-5000
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Milagros D Samaniego-Picota, MD
Phone: 734-771-9819
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655 West Baltimore Street
Baltimore, Maryland 21201
(410) 706-7410
Principal Investigator: Jonathan Bromoberg, MD PhD
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Birmingham, Alabama 35294
Principal Investigator: Roslyn Mannon, MD
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Harrisburg, Pennsylvania
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Richmond, Virginia 23235
Principal Investigator: Gaurav Gupta, MD
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Saint Louis, Missouri 63110
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Vienna,
Principal Investigator: Georg Boehmig, MD PhD
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