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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
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)
Links to Related Resources
Authorized Data Access Requests
Study Attribution
  • Study Chairs
    • 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.
  • Funding Source
    • National Institutes of Health, Bethesda, MD, USA.