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 19, 2020
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Condition or disease |
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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 |
Estimated Enrollment : | 500 participants |
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 |
Study Start Date : | May 2011 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2022 |
Group/Cohort |
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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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- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

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 | 1 780 492-6160 | phallora@ualberta.ca | |
Contact: Konrad S Famulski, PhD DSc | 1 780 4921725 | konrad@ualberta.ca |

Principal Investigator: | Philip F Halloran, MD PhD | University of Alberta |
Other 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 |
Other Study ID Numbers: |
ATAGC-001 |
First Posted: | February 18, 2011 Key Record Dates |
Last Update Posted: | November 19, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
global gene expression molecular diagnostic classifiers |