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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 : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Philip Halloran, University of Alberta

Study Description
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Brief Summary:
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 or disease
Validation Study of Molecular Diagnostic System Development of Reporting System for Molecular Diagnosis Incorporate Molecular Diagnosis Into Diagnostic Standards

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.

Study Design
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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 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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Group/Cohort
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).


Outcome Measures
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Primary Outcome Measures :
  1. Validate the Integrated Diagnostic System in the International Collaborative Microarray (INTERCOM) Study [ Time Frame: 2013-2016 ]
    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 :
  1. 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.

  2. 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

Eligibility Criteria
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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
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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Information from the National Library of Medicine

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


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

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Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Philip F Halloran, MD PhD University of Alberta
More Information
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Publications of Results:

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     History of Changes
Other Study ID Numbers: ATAGC-001
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
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