A National Registry For Pulmonary Alveolar Proteinosis

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT02461615
Status
Recruiting

Conditions

  • Pulmonary Alveolar Proteinosis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

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

Key Dates

Start date
Apr 30, 2015
Status verified
Mar 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Registry Participants
    All participants who participate in the National PAP Registry will be put into this cohort and observed over approximately 5 years.

Primary Outcome Measure

DBS card GM-CSF autoantibody levels to diagnose Autoimmune PAP [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Brenna C Carey, MS, PhD
513-636-8916

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