Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation
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|ClinicalTrials.gov Identifier: NCT01299168|
Recruitment Status : Recruiting
First Posted : February 18, 2011
Last Update Posted : November 21, 2017
|Condition or disease|
|Validation Study of Molecular Diagnostic System Development of Reporting System for Molecular Diagnosis Incorporate Molecular Diagnosis Into Diagnostic Standards|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Multi-centric Observational Study to Analyse the Diagnostic Molecular Features in the Clinical Setting of Kidney Allograft Biopsies|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
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).
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299168
|Contact: Philip F Halloran, MD PhD||1 780 firstname.lastname@example.org|
|Contact: Konrad S Famulski, PhD DSc||1 780 email@example.com|
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|Principal Investigator:||Philip F Halloran, MD PhD||University of Alberta|