Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation

Sponsor

University of Alberta (Other)

Overall Status

Recruiting

CT.gov ID

NCT01299168

Collaborator

(none)

500

Enrollment

Locations

157

Duration (Months)

19.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Validation Study of Molecular Diagnostic System Development of Reporting System for Molecular Diagnosis Incorporate Molecular Diagnosis Into Diagnostic Standards

Detailed Description

The study has enrolled so far 3007 biopsies from 2309 participants and the results are analyzed for these biopsies. Follow-up data is, and will be collected.

Study Design

Study Type:

Observational

Anticipated 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 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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

Primary Outcome Measures

Validate the Integrated Diagnostic System in the International Collaborative Microarray (INTERCOM) Study [2013-2016]
The rejection classifier predicts Banff diagnosis of any rejection: ABMR, TCMR, or mixed ABMR and TCMR; The TCMR classifier predicts the presence of Banff TCMR lesions/diagnoses; The ABMR classifier predicts the presence of ABMR lesions; In late (>1yr) biopsies for clinical indications, the failure classifier predicts failure within three years.

Secondary Outcome Measures

Demonstrate the feasibility of molecular phenotyping of 300 + 500 kidney transplant biopsies for clinical indications. [2014-2016]
To test the hypothesis that the molecular phenotype of a newly acquired sample predicts the histologic and clinical features of this sample.
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. [2015-2016]
Refine the reports based on feedback from the participants.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294-0006
2	University of Maryland School of Medicine	Baltimore	Maryland	United States	21209
3	University of Michigan Health System	Ann Arbor	Michigan	United States	48109-5395
4	University of Minnesota	Minneapolis	Minnesota	United States	55455
5	Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
6	Montefiore Medical Center	Bronx	New York	United States
7	Pinnacle Transplant Associates	Harrisburg	Pennsylvania	United States
8	Texas Transplant Institute - Methodist Healthcare System	San Antonio	Texas	United States	78229
9	Virginia Commonwealth University School of Medicine	Richmond	Virginia	United States	23298
10	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin	United States	WI 53705
11	Medical University of Vienna	Vienna		Austria
12	Department of Medicine, University of Alberta	Edmonton	Alberta	Canada	T6G 2S2
13	University of British Columbia, St. Paul's Hospital	Vancouver	British Columbia	Canada
14	University Hospital Merkur	Zagreb		Croatia
15	Institute for Experimental and Clinical Medicine (IKEM)	Prague		Czechia
16	Hopital Necker	Paris		France
17	Hopital St. Louis	Paris		France
18	Charité - Universitätmedizin Berlin	Berlin		Germany
19	Medizinische Hochschule	Hannover		Germany	30625
20	Beaumont Hospital	Dublin		Ireland
21	Department of Surgery, University of Usan, College of Medicine	Seoul		Korea, Republic of	05505
22	Pomeranian Medical University in Szczecin	Szczecin		Poland
23	University of Ljubljana	Ljubljana		Slovenia
24	Vall d'Hebron Hospital	Barcelona		Spain	08035
25	University Hospital Zurich	Zürich		Switzerland	8091
26	Manchester Royal Infirmary	Manchester		United Kingdom	M13 9WL

Sponsors and Collaborators

University of Alberta

Investigators

Principal Investigator: Philip F Halloran, MD PhD, University of Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Philip Halloran, Professor, University of Alberta

ClinicalTrials.gov Identifier:

NCT01299168

Other Study ID Numbers:

ATAGC-001

First Posted:

Feb 18, 2011

Last Update Posted:

Aug 22, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Philip Halloran, Professor, University of Alberta

global gene expression

molecular diagnostic classifiers

Additional relevant MeSH terms:

Disease

Study Results

No Results Posted as of Aug 22, 2022