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A National Registry For Pulmonary Alveolar Proteinosis

Recruitingn/aAges any - anyAllChildren's Hospital Medical Center, Cincinnati
NCT02461615 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

The major goal of Part A of this study is to establish a National PAP Registry to help make reliable new research tests available to doctors to improve the diagnosis of PAP, increase awareness and knowledge of PAP, and give patients a 'seat at the table' in planning and conducting PAP research including the clinical testing of several new potential therapies. The major goal of Part B of this study is to define the natural history of autoimmune PAP (aPAP), develop a disease severity score that reflects how aPAP patients feel and function, and to develop and test novel tools to measure the severity of aPAP lung disease. Funding Source - FDA OOPD

Sign in to get the eligibility rules as simple questions to take to your doctor.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria for Part A and Part B: * Written informed consent and assent, if applicable Inclusion Criteria for Part A (Cross Sectional Study of PAP Syndrome) * History of chest computed tomogram or chest radiograph findings compatible with PAP * History of diagnosis of PAP made by at least one of the following methods: * Positive (Abnormal) serum GMAb test -OR- * Lung biopsy clearly documenting the presence of PAP of any type or degree -OR- * Bronchoalveolar lavage cytology compatible with PAP -OR- * Recessive or compound mutations in genes known to cause PAP, i.e. GM-CSF receptor ฮฑ or ฮฒ chain, GM-CSF, surfactant protein B or C or ABCA3, ABCG1, ABCA1, TTF1 Inclusion Criteria For Part B (Longitudinal \& PRO Survey Study of autoimmune PAP Patients) * Diagnosis of autoimmune PAP as indicated by: * Positive (Abnormal) Serum GMAb Test -AND- * History of chest CT or x-rays findings compatible with PAP -OR- * Lung biopsy clearly documenting the presence of PAP of any type or degree -OR- * Bronchoalveolar lavage cytology compatible with PAP Exclusion Criteria or Part A and Part B: * Individuals who have a serious medical illness that, in the opinion of the investigator, is likely to interfere with completion of the study will be excluded. For Part A (Cross-sectional Study of PAP Syndrome) * Individuals that do not have a diagnosis of PAP For Part B (Longitudinal \& PRO Survey Study of autoimmune PAP Patients) * Individuals that do not have a diagnosis of autoimmune PAP
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What it tests

  • Not listed
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Where

1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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