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Procurement and Analysis of Specimens From Individuals With Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT00084305
Recruitment Status : Recruiting
First Posted : June 10, 2004
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Pulmonary Fibrosis

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.

Study Design

Study Type : Observational
Estimated Enrollment : 500 participants
Official Title: Procurement and Analysis of Specimens From Individuals With Pulmonary Fibrosis
Study Start Date : June 9, 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Individuals who are 18 years of age or older with any of the following:

Idiopathic pulmonary fibrosis (defined by either an open lung biopsy demonstrating pulmonary fibrosis and/or HRCT scan findings consistent with idiopathic pulmonary fibrosis as outlined 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),

Pulmonary fibrosis associated with rheumatoid arthritis [defined by 1987 American College of Rheumatology Revised Criteria for the Classification of RA], 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 (i.e., asbestos, silica, coal, beryllium) or exposure to drugs associated with pulmonary fibrosis,

Uncontrolled ischemic heart disease,

Other collagen vascular disorders (i.e. systemic lupus erythematosus, scleroderma, polymyositis, mixed connective tissue disease),

Uncorrectable bleeding diathesis,

Pregnancy or lactation, or

Inability to give informed consent.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00084305


Contacts
Contact: Bernadette R Gochuico, M.D. (301) 451-7979 gochuicb@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Human Genome Research Institute (NHGRI)
Investigators
Principal Investigator: Bernadette R Gochuico, M.D. National Human Genome Research Institute (NHGRI)
More Information

Additional Information:
Publications:
Responsible Party: National Human Genome Research Institute (NHGRI)
ClinicalTrials.gov Identifier: NCT00084305     History of Changes
Other Study ID Numbers: 040211
04-HG-0211
First Posted: June 10, 2004    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: August 11, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) ):
Bronchoscopy
Pulmonary Fibrosis
Lung Biopsy (Clinically-Indicated)
Hereditary Pulmonary Fibrosis
Healthy Volunteer
HV

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases