Pulmonary Fibrosis Clinical Trial in Bethesda MD
NCT00084305
| Observational
This study is looking to recruit 500 Participants
The etiology of pulmonary fibrosis is unknown. Analyses of blood, genomic DNA, and specimens
procured by bronchoscopy, lung biopsy, lung transplantation, clinically-indicated
extra-pulmonary biopsies, or post-mortem examination from individuals with this disorder may
contribute to our understanding of the pathogenic mechanisms of pulmonary fibrosis. The
purpose of this protocol is to procure and analyze blood, genomic DNA, and specimens by
bronchoscopy, lung biopsy, lung transplantation, extra-pulmonary biopsies, or post-mortem
examination from subjects with pulmonary fibrosis. In addition, blood, genomic DNA,
clinically-indicated extra-pulmonary biopsies, as well as bronchoscopy and post-mortem
examination specimens may be procured and analyzed from relatives of subjects with hereditary
forms of pulmonary fibrosis; blood, genomic DNA, and bronchoscopy specimens may be procured
from healthy research volunteers....
Details for the study
Population
Patients with pulmonary fibrosis@@@@@@
Brief Title
Analysis of Specimens From Individuals With Pulmonary Fibrosis
Official Title
Analysis of Specimens From Individuals With Pulmonary Fibrosis
Brief Summary
The etiology of pulmonary fibrosis is unknown. Analyses of blood, genomic DNA, and specimens
<br /> procured by bronchoscopy, lung biopsy, lung transplantation, clinically-indicated
<br /> extra-pulmonary biopsies, or post-mortem examination from individuals with this disorder may
<br /> contribute to our understanding of the pathogenic mechanisms of pulmonary fibrosis. The
<br /> purpose of this protocol is to procure and analyze blood, genomic DNA, and specimens by
<br /> bronchoscopy, lung biopsy, lung transplantation, extra-pulmonary biopsies, or post-mortem
<br /> examination from subjects with pulmonary fibrosis. In addition, blood, genomic DNA,
<br /> clinically-indicated extra-pulmonary biopsies, as well as bronchoscopy and post-mortem
<br /> examination specimens may be procured and analyzed from relatives of subjects with hereditary
<br /> forms of pulmonary fibrosis; blood, genomic DNA, and bronchoscopy specimens may be procured
<br /> from healthy research volunteers....
Detailed Description
The etiology of pulmonary fibrosis is unknown. Analyses of blood, genomic DNA, and specimens
procured by bronchoscopy, lung biopsy, lung transplantation, clinically-indicated
extra-pulmonary biopsies, or post-mortem examination from individuals with this disorder may
contribute to our understanding of the pathogenic mechanisms of pulmonary fibrosis. The
purpose of this protocol is to procure and analyze blood, genomic DNA, and specimens by
bronchoscopy, lung biopsy, lung transplantation, extra-pulmonary biopsies, or post-mortem
examination from subjects with pulmonary fibrosis. In addition, blood, genomic DNA,
clinically-indicated extra-pulmonary biopsies, as well as bronchoscopy and post-mortem
examination specimens may be procured and analyzed from relatives of subjects with hereditary
forms of pulmonary fibrosis; blood, genomic DNA, and bronchoscopy specimens may be procured
from healthy research volunteers.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Procure and analyze
The objectives and specific aims of this protocol are to procure and analyze blood and cell/tissue specimens from individuals with pulmonary fibrosis, relatives of subjects with familial pulmonary fibrosis, and healthy research volunteers.
Study Criteria
INCLUSION CRITERIA:
Individuals who are 18 years of age or older with any of the following:
- Idiopathic pulmonary fibrosis [defined by the American Thoracic Society/European
Respiratory Society guidelines],
- Familial pulmonary fibrosis [defined as idiopathic pulmonary fibrosis in two or more
first-degree relatives],
- Relatives of patients with hereditary pulmonary fibrosis,
- Hermansky-Pudlak syndrome (diagnosed by paucity or deficiency of platelet dense bodies
on whole mount electron microscopy or by genetic testing),
- Pulmonary fibrosis associated with collagen vascular diseases or autoinflammatory
disorders,
- Pulmonary fibrosis post-COVID-19 [i.e., pulmonary fibrosis in an individual recovering
from SARS-CoV-2 infection], or
- Healthy research volunteers by history and indicated tests (individuals without
history of chronic pulmonary disorder, collagen vascular disease, or bleeding
disorder).
EXCLUSION CRITERIA:
Individuals with any of the following:
- Significant inhalational exposure to fibrogenic fibers or dusts or exposure to drugs
associated with pulmonary fibrosis,
- Uncontrolled ischemic heart disease,
- Uncorrectable bleeding diathesis,
- Pregnancy or lactation (excluded due to exposure of unnecessary risks), or
- Inability to give informed consent (excluded due to exposure of unnecessary risks).