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NCT01299168 · ClinicalTrials.gov registry record
Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation
A clinical trial of Validation Study of Molecular Diagnostic System and Development of Reporting System for Molecular Diagnosis, sponsored by University of Alberta.
- Recruiting
- Registry status
- 500
- Enrollment target
- 20
- Study locations
NCT01299168 is a study of Validation Study of Molecular Diagnostic System and Development of Reporting System for Molecular Diagnosis that is actively recruiting participants, run by University of Alberta. The registered enrollment target is 500 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT01299168, a study of Validation Study of Molecular Diagnostic System and Development of Reporting System for Molecular Diagnosis, is actively recruiting participants, sponsored by University of Alberta.
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 20
- Study locations
Study 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 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.
Conditions Studied
Study Locations (20)
Other
- Medical University of Vienna - Vienna
- University Hospital Merkur - Zagreb
- Institute for Experimental and Clinical Medicine (IKEM) - Prague
- Hopital Necker - Paris
- Hopital St. Louis - Paris
- Charité - Universitätmedizin Berlin - Berlin
- Medizinische Hochschule - Hanover
- Beaumont Hospital - Dublin
Alabama
- University of Alabama - Birmingham
Maryland
- University of Maryland School of Medicine - Baltimore
Michigan
- University of Michigan Health System - Ann Arbor
Minnesota
- University of Minnesota - Minneapolis
Missouri
- Barnes-Jewish Hospital - St Louis
New York
- Montefiore Medical Center - The Bronx
Pennsylvania
- Pinnacle Transplant Associates - Harrisburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2011-05 |
| Est. Completion | 2027-06 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01299168
The ClinicalTrials.gov registry entry for NCT01299168 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alberta, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Validation Study of Molecular Diagnostic System appearing as the primary indexed condition, and to 0 interventions.
NCT01299168 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, Alabama, Maryland.
Frequently Asked Questions
What is clinical trial NCT01299168 about?
NCT01299168 is a clinical study titled "Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation". 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 ...
What is the current status of trial NCT01299168?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2011-05. Estimated completion is 2027-06.
What conditions does trial NCT01299168 study?
This clinical trial studies the following conditions: Validation Study of Molecular Diagnostic System, Development of Reporting System for Molecular Diagnosis, Incorporate Molecular Diagnosis Into Diagnostic Standards.
Who is sponsoring clinical trial NCT01299168?
This trial is sponsored by University of Alberta, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01299168 being conducted?
This trial has 20 study locations across Alabama, Maryland, Michigan, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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