Recruiting

Observational Study

Sponsor:

University of Alberta

Code:

NCT01299168

Conditions

Validation Study of Molecular Diagnostic System

Development of Reporting System for Molecular Diagnosis

Incorporate Molecular Diagnosis Into Diagnostic Standards

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Validation Study of Molecular Diagnostic System

Development of Reporting System for Molecular Diagnosis

Incorporate Molecular Diagnosis Into Diagnostic Standards

Study ID

NCT01299168

Start date

May, 2011

Status verified date

Jun, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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 and Locations

Central contacts

Philip F Halloran, MD PhD

1 780 492-6160phallora@ualberta.ca

Konrad S Famulski, PhD DSc

1 780 4921725konrad@ualberta.ca

Locations

Department of Medicine, University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2S2

Contacts

Soroush Shojai, MD

shojai@ualberta.ca

Principal Investigator:

Soroush Shojai, MD

More Information

Sponsor

University of Alberta

Last update posted

Jun 2, 2026

Last verified

Jun, 2026

Keywords

  • global gene expression
  • molecular diagnostic classifiers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-06-02.