Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

May 31, 2011

Status verified

Jun 2026

Primary completion

Dec 31, 2027

Completion

Jun 30, 2028

Study Design

Enrollment

500 participants (estimated)

Arms

• Arm: 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).

Primary Outcome Measure

Validate the Integrated Diagnostic System in the International Collaborative Microarray (INTERCOM) Study [ Time Frame: 2013-2016 ]

Central Contacts

• Philip F Halloran, MD PhD
  1 780 492-6160
  [email protected]
• Konrad S Famulski, PhD DSc
  1 780 4921725
  [email protected]

Locations (10)

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