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Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation
This study is currently recruiting participants.
Verified July 2017 by Philip Halloran, University of Alberta
Sponsor:
University of Alberta
Information provided by (Responsible Party):
Philip Halloran, University of Alberta
ClinicalTrials.gov Identifier:
NCT01299168
First received: February 16, 2011
Last updated: July 10, 2017
Last verified: July 2017
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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. Due to a considerable interest and support from participating Centers, the study is further extended to 1200 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.
| 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 Philip Halloran, University of Alberta:
Primary Outcome Measures:
- Validate the Integrated Diagnostic System in the International Collaborative Microarray (INTERCOM) Study [ Time Frame: 2013-2016 ]
- 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.
Secondary Outcome Measures:
- Demonstrate the feasibility of molecular phenotyping of 300 + 500 kidney transplant biopsies for clinical indications. [ Time Frame: 2014-2016 ]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 ]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 2017 (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=1100) and the results were analyzed for the first 300 collected biopsies. Follow-up data is, and will be collected.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01299168
Show 21 Study Locations
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 |
Show 21 Study Locations
Sponsors and Collaborators
University of Alberta
Investigators
| Principal Investigator: | Philip F Halloran, MD PhD | University of Alberta |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | July 10, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Philip Halloran, University of Alberta:
|
global gene expression molecular diagnostic classifiers |
ClinicalTrials.gov processed this record on July 27, 2017