RECRUITING

Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Multi-centric Observational Study to Analyse the Diagnostic Molecular Features in the Clinical Setting of Kidney Allograft Biopsies

Quick Facts

Study Start:2011-05
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01299168

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  1. * Patients will be excluded from the study if they decline participation or are unable to give informed consent.

Contacts and Locations

Study Contact

Philip F Halloran, MD PhD
CONTACT
1 780 492-6160
phallora@ualberta.ca
Konrad S Famulski, PhD DSc
CONTACT
1 780 4921725
konrad@ualberta.ca

Principal Investigator

Philip F Halloran, MD PhD
PRINCIPAL_INVESTIGATOR
University of Alberta

Study Locations (Sites)

University of Alabama
Birmingham, Alabama, 35294-0006
United States
University of Maryland School of Medicine
Baltimore, Maryland, 21209
United States
University of Michigan Health System
Ann Arbor, Michigan, 48109-5395
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Barnes-Jewish Hospital
Saint Louis, Missouri, 63110
United States
Montefiore Medical Center
Bronx, New York
United States
Pinnacle Transplant Associates
Harrisburg, Pennsylvania
United States
Texas Transplant Institute - Methodist Healthcare System
San Antonio, Texas, 78229
United States
Virginia Commonwealth University School of Medicine
Richmond, Virginia, 23298
United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, WI 53705
United States

Collaborators and Investigators

Sponsor: University of Alberta

  • Philip F Halloran, MD PhD, PRINCIPAL_INVESTIGATOR, University of Alberta

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2011-05
Study Completion Date2026-06

Study Record Updates

Study Start Date2011-05
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • global gene expression
  • molecular diagnostic classifiers

Additional Relevant MeSH Terms

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