Multicenter International Cross-Sectional Evaluation of Pulmonary Alveolar Proteinosis Trial

Completed

Conditions studied: Pulmonary Alveolar Proteinosis

In brief

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.

Key facts

Study ID

NCT03007134

Run by

Children's Hospital Medical Center, Cincinnati

People needed

73

Starts

2007-07-01

Expected to finish

2011-07-01

Last updated by the study team

2017-01-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• No established diagnosis of PAP
• Incomplete chart records in which >25% of the requested data is unable to be confirmed.

Where it is running

• Brody School of Medicine — Greenville, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Ruhrlandklinik Essen — Essen, Germany
• Clinica Malattie Apparato Respiratorio Università di Pavia — Pavia, Italy
• University of Niigata Medical and Dental School — Niigata, Japan
• NHO Kinki-Chuo Chest Center — Osaka, Japan

Full record on ClinicalTrials.gov

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