Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation
NCT01299168 · View on ClinicalTrials.gov ↗
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?
Always speak with your doctor before enrolling in a clinical 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. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 135 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Validation Study of Molecular Diagnostic System appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01299168 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, Alabama, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01299168?
This trial is sponsored by University of Alberta, which has 135 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.