MICEPAP Trial

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.]]> RLD 5706 Forms (Jun 2007)5706 DocsCorrections for the MICEPAP form from October 1, 2008CASE REPORT FORM (Dec 2008)Eligibility Form (Jun 2008)Eligibility Form (Jun 2007)CASE REPORT FORM (Nov 2008)CASE REPORT FORM (Oct 2008)RLD 5706 Forms (Jun 2008)DEMOGRAPHICS FORMELIGIBILITY FORM (Dec 2008)ELIGIBILITY FORM (Nov 2008)ELIGIBILITY FORM (Sep 2008)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 Activated July 3, 2008 First Accrual July 3, 2008 Study Closed to Accrual in data analysis on January 13, 2015 ]]>