Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

University of Alberta

Status: Enrolling

Conditions: Validation Study of Molecular Diagnostic System; Incorporate Molecular Diagnosis Into Diagnostic Standards; Development of Reporting System for Molecular Diagnosis

Study type: Observational

Funder types: Other

Identifiers

NCT01299168

ATAGC-001

Details and patient eligibility

About

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.

Full description

The study has enrolled so far 3012 biopsies from 2313 participants and the results are analyzed for these biopsies. Follow-up data is, and will be collected.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Kidney Transplant Biopsies for Cause

Description:

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).