Lung Allograft Rejection Gene Expression Observational (LARGO) Study
NCT ID: NCT00751309
Last Updated: 2008-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
2044 participants
OBSERVATIONAL
2004-04-30
2009-01-31
Brief Summary
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Detailed Description
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At each study visit, blood specimens are collected from subjects, processed and stored in the sample archive, with corresponding patient information entered into the clinical database. The analysis plan for each study objective includes a defined sample selection protocol that stipulates the inclusion and exclusion criteria for both patients and samples, and also the required number of blood specimens for the molecular analyses to achieve statistical significance.
The diagnosis and treatment of acute cellular rejection remains a clinical management priority that is currently based on transbronchial biopsy. Gene expression profiling is a technology based on molecular biology that measures changes in the RNA levels of different genes expressed by circulating mononuclear cells in the peripheral blood. A key goal of the project is to use gene expression profiling to differentiate between the absence and presence of lung allograft acute cellular rejection, with the aim of using this novel information to develop a non-invasive diagnostic testing alternative.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Lung and heart-lung transplanted subjects.
Non-interventional
Post-transplantation observational study
Interventions
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Non-interventional
Post-transplantation observational study
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
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XDx
INDUSTRY
Responsible Party
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XDx, Inc.
Principal Investigators
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Kenneth C. Fang, MD
Role: STUDY_DIRECTOR
XDx, Inc.
Locations
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UCLA Division of Pulmonary and Critical Care
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Stanford University School of Medicine
Stanford, California, United States
University of Colorado
Aurora, Colorado, United States
Mayo Clinic Transplant Center
Jacksonville, Florida, United States
University of Michigan Health Systems
Ann Arbor, Michigan, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Columbia University College of Physicians and Surgeons
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Washington Medical Center
Seattle, Washington, United States
University Hospital and Clinics
Madison, Wisconsin, United States
Medizinische Universität Wien
Vienna, , Austria
Hospital for Sick Children
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Medizinische Hochschule Hannover
Hanover, , Germany
Freeman Hospital
High Heaton, Newcastle upon Tyne, United Kingdom
Countries
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Related Links
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Information on molecular expression testing
Sponsor's website
Other Identifiers
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LARGO
Identifier Type: -
Identifier Source: org_study_id