Pulmonary Alveolar Proteinosis Clinical Trials

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A National Registry For Pulmonary Alveolar Proteinosis

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Written informed consent and assent, if applicable

• 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 α or β chain, GM-CSF, surfactant protein B or C or ABCA3, ABCG1, ABCA1, TTF1

• 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

Locations
United States
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Brenna C Carey, Ms, PhD
Brenna.Carey@cchmc.org
513-636-8916
Time Frame
Start Date: 2015-04
Estimated Completion Date: 2030-12
Participants
Target number of participants: 500
Treatments
Registry Participants
All participants who participate in the National PAP Registry will be put into this cohort and observed over approximately 5 years.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati
Collaborators: National Center for Advancing Translational Sciences (NCATS), Rare Diseases Clinical Research Network, National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov