Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
Philip Halloran, University of Alberta
ClinicalTrials.gov Identifier:
NCT01299168
First received: February 16, 2011
Last updated: February 2, 2015
Last verified: February 2015
  Purpose

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. 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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-centric Observational Study to Analyse the Diagnostic Molecular Features in the Clinical Setting of Kidney Allograft Biopsies

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Validate the Integrated Diagnostic System in the International Collaborative Microarray (INTERCOM) Study [ Time Frame: 2013-2016 ] [ Designated as safety issue: No ]
    1. The rejection classifier predicts Banff diagnosis of any rejection: ABMR, TCMR, or mixed ABMR and TCMR;
    2. The TCMR classifier predicts the presence of Banff TCMR lesions/diagnoses;
    3. The ABMR classifier predicts the presence of ABMR lesions;
    4. In late (>1yr) biopsies for clinical indications, the failure classifier predicts failure within three years.


Secondary Outcome Measures:
  • Demonstrate the feasibility of molecular phenotyping of 300 + 500 kidney transplant biopsies for clinical indications. [ Time Frame: 2014-2016 ] [ Designated as safety issue: No ]
    To test the hypothesis that the molecular phenotype of a newly acquired sample predicts the histologic and clinical features of this sample.

  • Demonstrate the feasibility of molecular phenotyping of 500 biopsies in real time i.e. returning the molecular phenotyping report in two working days upon sample arrival. [ Time Frame: 2015-2016 ] [ Designated as safety issue: No ]
    Refine the reports based on feedback from the participants.


Biospecimen Retention:   Samples Without DNA

Needle kidney biopsy core as per local standard of care


Estimated Enrollment: 500
Study Start Date: May 2011
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

Detailed Description:

The study is now enrolling (N=800) and the results are being analyzed for the first 300 collected biopsies. Follow-up data is, and will be collected.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population includes patients with a functioning kidney transplant undergoing a biopsy for clinicalindications as standard of care to determine the cause of their graft dysfunction (deterioration in graft function, delayed graft function, proteinuria).

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299168

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

Locations
United States, Maryland
University of Maryland School of Medicine Recruiting
Baltimore, Maryland, United States, 21209
Contact: Jonathan Bromberg, MD PhD       jbromberg@smail.umaryland.edu   
Contact: Amanda Bartosic       abartosic@smail.umaryland.edu   
Principal Investigator: Jonathan Bromoberg, MD PhD         
United States, Minnesota
University of Minnesota Active, not recruiting
Minneapolis, Minnesota, United States, 55455
United States, Virginia
Virginia Commonwealth University School of Medicine Recruiting
Richmond, Virginia, United States, 23298
Contact: Gaurav Gupta, MD       ggupta@mcvh-vcu.edu   
Contact: Mary Baldecchi       mbaldecchi@mcvh-vcu.edu   
Principal Investigator: Gaurav Gupta, MD         
Austria
Medical University of Vienna Recruiting
Vienna, Austria
Contact: Georg Boehmig, MD PhD       georg.boehmig@meduniwien.ac.at   
Contact: Farsad Eskandry, MD       farsad.eskandary@meduniwien.ac.at   
Principal Investigator: Georg Boehmig, MD PhD         
Canada, British Columbia
University of British Columbia, St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: John S Gill, MD MS       JGill@providencehealth.bc.ca   
Contact: Jesmint Dhillon       jdhillon@providencehealth.bc.ca   
Principal Investigator: John Gill, MD MS         
France
Hopital Necker Recruiting
Paris, France
Contact: Alexandre Loupy, MD PhD       alexandreloupy@gmail.com   
Contact: Camilo Ulloa       camilouolla@gmail.com   
Principal Investigator: Alexandre Loupy, MD PhD         
Hopital St. Louis Recruiting
Paris, France
Contact: Carmen Lefaucheur, MD PhD       carmen.lefaucheur@wanadoo.fr   
Contact: Clement Gosset, MD       gossetclement@yahoo.fr   
Principal Investigator: Carmen Lefaucheur, MD PhD         
Germany
Medizinische Hochschule Recruiting
Hannover, Germany, 30625
Contact: Gunilla Einecke, MD PhD       einecke.gunilla@mh-hannover.de   
Principal Investigator: Gunilla Einecke, MD PhD         
Ireland
Beaumont Hospital Recruiting
Dublin, Ireland
Contact: Declan de Freitas, MD PhD       declandefreitas@beaumont.ie   
Principal Investigator: Declan de Freitas, MD PhD         
Spain
Vall d'Hebron Hospital Recruiting
Barcelona, Spain, 08035
Contact: Daniel Seron, MD       dseron@vhebron.net   
Contact: Oreto Prat Canet       oprat@vhebron.net   
Principal Investigator: Daniel Seron, MD         
Sub-Investigator: Joana Selares-Roig, MD         
United Kingdom
Manchester Royal Infirmary Active, not recruiting
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Philip F Halloran, MD PhD University of Alberta
  More Information

Publications:
Responsible Party: Philip Halloran, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01299168     History of Changes
Other Study ID Numbers: ATAGC-001
Study First Received: February 16, 2011
Last Updated: February 2, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
global gene expression
molecular diagnostic classifiers

ClinicalTrials.gov processed this record on February 27, 2015