Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

ClinicalTrials.gov ID: NCT01299168

Public ClinicalTrials.gov record NCT01299168. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 11, 2026, 10:36 AM EDT

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Official title

Multi-centric Observational Study to Analyse the Diagnostic Molecular Features in the Clinical Setting of Kidney Allograft Biopsies

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01299168
Recruitment status: Recruiting
Study type: Observational
Phase: Not listed
Lead sponsor: University of Alberta; Other
Enrollment: 500 participants

Conditions and interventions

Conditions

Interventions

Not listed

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 30, 2011
Primary completion: Nov 30, 2027
Completion: May 31, 2028
Last update posted: Jun 1, 2026

2011 – 2028

United States locations

U.S. sites: 10
U.S. states: 10
U.S. cities: 10

Facility	City	State	ZIP	Site status
University of Alabama	Birmingham	Alabama	35294-0006	Completed
University of Maryland School of Medicine	Baltimore	Maryland	21209	Completed
University of Michigan Health System	Ann Arbor	Michigan	48109-5395	Completed
University of Minnesota	Minneapolis	Minnesota	55455	Completed
Barnes-Jewish Hospital	St Louis	Missouri	63110	Completed
Montefiore Medical Center	The Bronx	New York	—	Completed
Pinnacle Transplant Associates	Harrisburg	Pennsylvania	—	Completed
Texas Transplant Institute - Methodist Healthcare System	San Antonio	Texas	78229	Completed
Virginia Commonwealth University School of Medicine	Richmond	Virginia	23298	Completed
University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin	WI 53705	Completed

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01299168, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 1, 2026 · Synced Sep 11, 2026

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