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Sponsored by: |
XDx |
Information provided by: | XDx |
ClinicalTrials.gov Identifier: | NCT00751309 |
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.
Condition | Intervention |
Graft Rejection Lung Disease |
Other: Non-interventional |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Lung Allograft Rejection Gene Expression Observational (LARGO) Study |
venous blood plasma
Estimated Enrollment: | 2100 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
1
Lung and heart-lung transplanted subjects.
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Other: Non-interventional
Post-transplantation observational study
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LARGO is a prospective, multi-center, international observational study with participating centers in the United States, Canada and Europe. The target enrollment for study completion is 2,100 subjects.
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Lung and heart-lung transplant recipients who will undergo transbronchial biopsy.
Inclusion Criteria:
Exclusion Criteria:
Contact: Joyce Alejo-Stone | (415) 287-2301 | jalejo-stone@xdx.com |
United States, California | |||||
Stanford University School of Medicine | Recruiting | ||||
Stanford, California, United States, 94305 | |||||
Contact: Val Scott, RN 650-725-8082 valval@stanford.edu | |||||
Principal Investigator: David Weill, MD | |||||
UCLA Division of Pulmonary and Critical Care | Recruiting | ||||
Los Angeles, California, United States, 90095 | |||||
Contact: Troy Overfield-Blain 310-206-4319 TOverfield@mednet.ucla.edu | |||||
Principal Investigator: David Ross, MD | |||||
University of California, San Francisco | Recruiting | ||||
San Francisco, California, United States, 94117 | |||||
Contact: Jill Obata, RN 415-353-4148 obataj@surgery.ucsf.edu | |||||
Principal Investigator: Jeffrey A Golden, MD | |||||
Sub-Investigator: George H Caughey, MD | |||||
United States, Colorado | |||||
University of Colorado | Recruiting | ||||
Aurora, Colorado, United States, 80045 | |||||
Contact: Heidi Bougher, RN 720-848-2247 Heidi.Bougher@uch.edu | |||||
Principal Investigator: Martin R Zamora, MD | |||||
United States, Florida | |||||
Mayo Clinic Transplant Center | Completed | ||||
Jacksonville, Florida, United States, 32224 | |||||
United States, Michigan | |||||
University of Michigan Health Systems | Recruiting | ||||
Ann Arbor, Michigan, United States, 48109 | |||||
Contact: Mary Maliarik, PhD 734-615-8627 marymali@med.umich.edu | |||||
Principal Investigator: Kevin Chan, MD | |||||
United States, Missouri | |||||
Washington University School of Medicine | Recruiting | ||||
St. Louis, Missouri, United States, 63110 | |||||
Contact: Aviva Aloush, RN 314-747-1931 alousha@wudosis.wustl.edu | |||||
Principal Investigator: Elbert Trulock, MD | |||||
St. Louis Children's Hospital | Recruiting | ||||
St. Louis, Missouri, United States, 63110 | |||||
Contact: Dee Dee Epstein, RN 314-454-4131 epsteind@wudosis.wustl.edu | |||||
Principal Investigator: Stuart C Sweet, MD, PhD | |||||
United States, New York | |||||
Columbia University College of Physicians and Surgeons | Recruiting | ||||
New York, New York, United States, 10032 | |||||
Contact: Ana J Alvarez, MPA 212-342-1518 aa461@columbia.edu | |||||
Principal Investigator: Jessie S Wilt, MD | |||||
Principal Investigator: Selim M Arcasoy, MD | |||||
United States, North Carolina | |||||
Duke University Medical Center | Recruiting | ||||
Durham, North Carolina, United States, 27710 | |||||
Contact: Jason Hawkins, RN 919-681-5775 jason.hawkins@duke.edu | |||||
Contact: Diana Stephenson, RN diana.stephenson@duke.edu | |||||
Principal Investigator: R. Duane Davis, MD | |||||
Sub-Investigator: Scott M Palmer, MD, MHS | |||||
United States, Ohio | |||||
The Cleveland Clinic | Recruiting | ||||
Cleveland, Ohio, United States, 44195 | |||||
Contact: John Nocero 216-444-2140 noceroj@ccf.org | |||||
Principal Investigator: Marie Budev, DO | |||||
United States, Pennsylvania | |||||
University of Pennsylvania | Not yet recruiting | ||||
Philadelphia, Pennsylvania, United States, 19104 | |||||
Contact: Karen McGibney 215-573-8906 mcgibney@upenn.edu | |||||
Principal Investigator: Jason D Christie, MD | |||||
University of Pittsburgh | Active, not recruiting | ||||
Pittsburgh, Pennsylvania, United States, 15261 | |||||
United States, Washington | |||||
University of Washington Medical Center | Recruiting | ||||
Seattle, Washington, United States, 98195 | |||||
Contact: Connie Wallum, RN 206-685-8794 cwallum@u.washington.edu | |||||
Principal Investigator: Michael S Mulligan, MD | |||||
Sub-Investigator: Jeffrey D Edelman, MD | |||||
United States, Wisconsin | |||||
University Hospital and Clinics | Recruiting | ||||
Madison, Wisconsin, United States, 53792 | |||||
Contact: Holly Thomas, MSSW 608-890-8603 HThomas@uwhealth.org | |||||
Principal Investigator: Keith Meyer, MD | |||||
Austria | |||||
Medizinische Universität Wien | Recruiting | ||||
Vienna, Austria, 1090 | |||||
Contact: Florian Distel, MD +43 1 40400 7989 florian.distel@meduniwien.ac.at | |||||
Principal Investigator: Peter Jaksch, MD | |||||
Canada, Ontario | |||||
Hospital for Sick Children | Recruiting | ||||
Toronto, Ontario, Canada, M5G 1X8 | |||||
Contact: Azad Sassan, MSc, MLT 416-340-4800 ext 6224 sassan.azad@uhn.on.ca | |||||
Principal Investigator: Melinda Solomon, MD, FRCPC | |||||
Toronto General Hospital | Recruiting | ||||
Toronto, Ontario, Canada, M5G 2C4 | |||||
Contact: Sassan Azad, MSc, MLT 416-340-4800 ext 6224 sassan.azad@uhn.on.ca | |||||
Principal Investigator: Shaf Keshavjee, MD | |||||
Germany | |||||
Medizinische Hochschule Hannover | Recruiting | ||||
Hannover, Germany, 30625 | |||||
Contact: Yves Scheibner +49 511/ 532 4086 scheibner.yves@mh-hannover.de | |||||
Principal Investigator: Martin Strueber, MD, PhD | |||||
Sub-Investigator: Axel Haverich, MD | |||||
United Kingdom, Newcastle upon Tyne | |||||
Freeman Hospital | Recruiting | ||||
High Heaton, Newcastle upon Tyne, United Kingdom, NE7 7DN | |||||
Contact: Therese Small 0191 2231148 therese.small@nuth.northy.nhs.uk | |||||
Principal Investigator: Paul Corris, MD |
XDx |
Study Director: | Kenneth C. Fang, MD | XDx, Inc. |
Information on molecular expression testing 
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Sponsor's website 
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Responsible Party: | XDx, Inc. ( Kenneth C. Fang, MD ) |
Study ID Numbers: | LARGO |
First Received: | September 10, 2008 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00751309 |
Health Authority: | United States: Institutional Review Board; United Kingdom: Research Ethics Committee; Germany: Ethics Commission; Canada: Ethics Review Committee; Austria: Ethikkommission |
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