Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation
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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 |
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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 |
- Validate the Integrated Diagnostic System in the International Collaborative Microarray (INTERCOM) Study [ Time Frame: 2013-2016 ] [ Designated as safety issue: No ]
- The rejection classifier predicts Banff diagnosis of any rejection: ABMR, TCMR, or mixed ABMR and TCMR;
- The TCMR classifier predicts the presence of Banff TCMR lesions/diagnoses;
- The ABMR classifier predicts the presence of ABMR lesions;
- In late (>1yr) biopsies for clinical indications, the failure classifier predicts failure within three years.
- 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 |
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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).
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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 |
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).
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01299168
| 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 |
| 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 | |
| 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:
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global gene expression molecular diagnostic classifiers |
ClinicalTrials.gov processed this record on February 27, 2015