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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 Type: Clinical Trial
  • Number of study subjects that have individual level data available through Authorized Access: 159

Authorized Access
Publicly Available Data (Public ftp)

Connect to the public download site. The site contains release notes and manifests. If available, the site also contains data dictionaries, variable summaries, documents, and truncated analyses.

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