NCT02461615 A National Registry For Pulmonary Alveolar Proteinosis
| NCT ID | NCT02461615 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Pulmonary Alveolar Proteinosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2015-04 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2015-04 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 α or β 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
Contact & Investigator
Bruce C Trapnell, MD
STUDY CHAIR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT02461615 clinical trial?
This trial is open to participants of all sexes, studying Pulmonary Alveolar Proteinosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02461615 currently recruiting?
Yes, NCT02461615 is actively recruiting participants. Contact the research team at Brenna.Carey@cchmc.org for enrollment information.
Where is the NCT02461615 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT02461615 clinical trial?
NCT02461615 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Bruce C Trapnell, MD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 500 participants.