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Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

NCT01299168 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-01-29

No results posted yet for this study

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

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Philip F Halloran, MD PhD · University of Alberta

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • United States
  • Austria
  • Canada
  • Croatia
  • Czechia
  • France
  • Germany
  • Ireland
  • Poland
  • Slovenia
  • South Korea
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01299168 on ClinicalTrials.gov