New Diagnostic System for Kidney Transplant Biopsies
Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation
Recruiting
Observational Study
Validation Study of Molecular Diagnostic SystemDevelopment of Reporting System for Molecular DiagnosisIncorporate Molecular Diagnosis Into Diagnostic Standards
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
500 (estimated)
Sponsor
University of Alberta · Other
Who this trial is looking for
This trial is looking for kidney transplant recipients over 18 years old who are having a biopsy. Participants will help test a new system designed to improve diagnosis and treatment based on their biopsy results.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I am a kidney transplant recipient.
My doctor has ordered a kidney biopsy for clinical reasons.
You may not be able to join if
I do not want to take part in the study.
I cannot give informed consent.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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 1500 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.
Trial Locations
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Eligibility 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 participati…
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.
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