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Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Philip Halloran, University of Alberta
ClinicalTrials.gov Identifier:
NCT01299168
First received: February 16, 2011
Last updated: October 12, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition
To Validate the Integrated Diagnostic System in the International Collaborative Microarray (INTERCOM)
Study
To Develop a Clinically Feasible and Useful Reporting System for Molecular, Histopathology and Integrated
Diagnosis
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:

U.S. FDA Resources

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
Groups/Cohorts
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.

  Eligibility

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).

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299168

Locations
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
Germany
Medizinische Hochschule
Hannover, Germany, 30625
Spain
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

No publications provided

Responsible Party: Philip Halloran, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01299168     History of Changes
Other Study ID Numbers: ATAGC-001
Study First Received: February 16, 2011
Last Updated: October 12, 2012
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on May 16, 2013