NCT00751309|Terminated
Study Stopped
Restructuring and refocus of company.
Lung Allograft Rejection Gene Expression Observational (LARGO) Study
LARGO
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Restructuring and refocus of company.
LARGO
Sponsor study identifier
observational
2,044
5 countries
20
Study Start
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The objective of the LARGO Study protocol is to collect peripheral blood samples, select associated lung biopsy pathology slides, and clinical data from lung transplant recipients to perform molecular analyses in association with the study endpoints. The primary objective is to use gene expression profiling of peripheral blood mononuclear cells to differentiate between the absence and presence of acute cellular rejection. The secondary objectives are to use other genomic and proteomic technologies to analyze RNA and protein in blood samples in relation to related clinical conditions. The overall goal is to apply novel molecular insights in the development of non-invasive molecular diagnostic tests for lung transplantation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 10, 2008
Actual (reported)September 11, 2008
Actual (reported)January 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Rejection episodes of at least moderate histologic grade which resulted in treatment of the patient with additional corticosteroids, anti-T cell antibodies, or total lymphoid irradiation.
Scheduled clinic visit
Obliterative Bronchiolitis diagnosed pathologically by biopsy or by a progressive decline in pulmonary function tests consistent with a diagnosis of Bronchiolitis Obliterans Syndrome (BOS).
Scheduled clinic visit
Allograft function as determined via pulmonary function tests.
Scheduled clinic visit
The absence of histologic rejection and normal or unchanged allograft function.
Scheduled clinic visit
Rejection of mild to moderate histologic severity prompting augmentation of the patient's chronic immunosuppressive regimen.
Scheduled clinic visit
Allograft dysfunction during the study period.
Scheduled clinic visit
Rejection of mild to moderate severity with allograft dysfunction prompting plasmapheresis or a diagnosis of "humoral" rejection.
Scheduled clinic visit
Lymphoproliferative disorder (aka post-transplant lymphoma).
Scheduled clinic visit
Graft Failure or Retransplantation.
Scheduled clinic visit
Lung and heart-lung transplanted subjects.
Post-transplantation observational study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Lung and heart-lung transplant recipients who will undergo transbronchial biopsy.
UCLA Division of Pulmonary and Critical Care
Los Angeles, California, 90095, United States
University of California, San Francisco
San Francisco, California, 94117, United States
Stanford University School of Medicine
Stanford, California, 94305, United States
University of Colorado
Aurora, Colorado, 80045, United States
Mayo Clinic Transplant Center
Jacksonville, Florida, 32224, United States
University of Michigan Health Systems
Ann Arbor, Michigan, 48109, United States
St. Louis Children's Hospital
venous blood plasma
Kenneth C. Fang, MD
XDx, Inc.
2,044 participants (actual enrollment reported by the registry).
First Submitted
September 10, 2008
First Posted
September 11, 2008
Study Start
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Documented CMV infection by culture, histology, or PCR, and at least one clinical sign or symptom of infection.
Scheduled clinic visit
Infections other than CMV, e.g. bacterial, other viral, and fungal infections.
Scheduled clinic visit
Contact the study team to confirm eligibility.
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Columbia University College of Physicians and Surgeons
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
University Hospital and Clinics
Madison, Wisconsin, 53792, United States
Medizinische Universität Wien
Vienna, 1090, Austria
Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Freeman Hospital
High Heaton, Newcastle upon Tyne, NE7 7DN, United Kingdom
Primary Completion
January 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 18, 2008
Record last verified: 2008-12
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Source: ClinicalTrials.gov.
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