Last updated on July 2020

Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT01299168

Find a site near you

Start Over

University of Alabama

Birmingham, AL United States
  Connect »

University of Minnesota

Minneapolis, MN United States
  Connect »

Barnes-Jewish Hospital

Saint Louis, MO United States
  Connect »

Pinnacle Transplant Associates

Harrisburg, PA United States
  Connect »

Manchester Royal Infirmary

Manchester, United Kingdom
  Connect »

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.