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- Study Description
The purpose of this study is to (1) compare a technically improved assay with an existing assay used to measure serum anti-GM-CSF antibodies in stored serum samples previously obtained from patients diagnosed with either primary, secondary, congenital or idiopathic pulmonary alveolar proteinosis (PAP), other chronic diseases or disease-free, healthy individuals; (2) determine the prevalence and levels of anti-GM-CSF autoantibodies and (3) define the breadth of the autoimmune antibody responses in primary PAP patients from the United States, Japan, Australia, and Europe using previously collected serum samples; and (4) using a chart review approach, compare the clinical, radiologic and laboratory features of primary PAP patients to determine if differences exist among patients in these globally geographically distributed regions.
- Study Design:
- Clinical Trial
- Study Type:
- Clinical Trial
- Total number of consented subjects: 159
- Subject Sample Telemetry Report (SSTR)
- Study Design:
- Authorized Access
- Publicly Available Data (Public ftp)
- Study Inclusion/Exclusion Criteria
Data and Serum Inclusion Criteria
- Data and Serum must be from individuals of any age with confirmed diagnosis of PAP based on the following criteria:
- Radiographic features consistent with PAP
- Pathological or cytological findings consistent with PAP determined by either open lung biopsy, transbronchial biopsy or bronchoalveolar lavage cell/fluid cytology
- Elevated anti-GM-CSF autoantibody concentration, when available
- Ability of the international PI's and their research coordinators to ship samples in compliance with this study
Data and Serum Exclusion Criteria
- No established diagnosis of PAP
- Incomplete chart records in which >25% of the requested data is unable to be confirmed
- Study History
- Study Activated July 3, 2008
- First Accrual July 3, 2008
- Study Closed to Accrual in data analysis on January 13, 2015
- Selected Publications
- Diseases/Traits Related to Study (MeSH terms)
- Primary Phenotype: Pulmonary Alveolar Proteinosis
- Links to Related Resources
- Authorized Data Access Requests
- Study Attribution
- Bruce Trapnell, MD. Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Participating Site Principal Investigators
- Koh Nakata, MD. University of Niigata Medical and Dental School, Niigata, Japan.
- John Seymour, MB. Peter Mac Hospital, Melbourne, Australia.
- Daniel Culver, MD. Cleveland Clinic Foundation, Cleveland, OH, USA.
- James Ellis, MD. National Jewish Medical and Research Center, Denver, CO, USA.
- Cliff Morgan, MD. Brompton Chest Hospital, London, UK.
- Maurizio Luisetti, MD. Clinica Malattie Apparato Respiratorio, Universita di Pavia, Italy.
- Mani Kavuru, MD. Brody School of Medicine Greenville, NC, USA.
- Ulrich Costabel, MD. Ruhrlandklinik Essen, Essen, Germany.
- Yoshikazu Inoue, MD. NHO Kinki-Chuo Chest Ctr.,Osaka, Japan.
- Jeffrey Krischer, PhD. Data Management and Coordinating Center University of South Florida, Tampa, FL, USA.
- National Institutes of Health, Bethesda, MD, USA.
- Study Chairs