Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Philip Halloran, University of Alberta Identifier:
First received: February 16, 2011
Last updated: September 4, 2013
Last verified: September 2013

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 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.

To Validate the Integrated Diagnostic System in the International Collaborative Microarray (INTERCOM)
To Develop a Clinically Feasible and Useful Reporting System for Molecular, Histopathology and Integrated
To Incorporate the Integrated Diagnostic System Into International Diagnostic Standards

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-centric Observational Study to Analyse the Diagnostic Molecular Features in the Clinical Setting of Kidney Allograft Biopsies

Resource links provided by NLM:

Further study details as provided by University of Alberta:

Biospecimen Retention:   Samples Without DNA

Needle kidney biopsy core as per local standard of care

Estimated Enrollment: 300
Study Start Date: May 2011
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).

Detailed Description:

The study is now fully enrolled (N=300) and the results are being analyzed. Follow-up data is being collected.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01299168

United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21209
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Medizinische Hochschule
Hannover, Germany, 30625
Vall d'Hebron Hospital
Barcelona, Spain, 08035
United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
University of Alberta
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Philip Halloran, Professor, University of Alberta Identifier: NCT01299168     History of Changes
Other Study ID Numbers: ATAGC-001
Study First Received: February 16, 2011
Last Updated: September 4, 2013
Health Authority: Canada: Ethics Review Committee processed this record on November 20, 2014