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Procurement and Analysis of Specimens From Individuals With Pulmonary Fibrosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
ClinicalTrials.gov Identifier:
NCT00084305
First received: June 9, 2004
Last updated: November 11, 2014
Last verified: May 2014

June 9, 2004
November 11, 2014
June 2004
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Complete list of historical versions of study NCT00084305 on ClinicalTrials.gov Archive Site
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Procurement and Analysis of Specimens From Individuals With Pulmonary Fibrosis
Procurement and Analysis of Specimens From Individuals With Pulmonary Fibrosis

The etiology of pulmonary fibrosis is unknown. Analysis of blood, genomic DNA, and specimens procured by bronchoscopy, lung biopsy, lung transplantation, or post-mortem examination from individuals with this disorder may contribute to our understanding of pathogenic mechanisms of pulmonary fibrosis. The purpose of this protocol is to obtain blood, genomic DNA, and specimens by bronchoscopy, lung biopsy, lung transplantation, or post-mortem examination from subjects with pulmonary fibrosis. In addition, blood, genomic DNA, as well as bronchoscopy and post-mortem examination specimens may be obtained from relatives of subjects with familial pulmonary fibrosis or healthy research volunteers.

The etiology of pulmonary fibrosis (PF) is unknown. Analyses of blood, genomic DNA, and specimens procured by bronchoscopy, lung biopsy, lung transplantation, or post-mortem examination from individuals with this disorder may contribute to our understanding of the pathogenic mechanisms of this disorder. The purpose of this protocol is to obtain blood, genomic DNA, and lung specimens from research subjects by bronchoscopy or lung biopsy, or lung tissue available either in the setting of lung transplantation, or post-mortem examination from subjects with pulmonary fibrosis. In addition, blood, genomic DNA, as well as bronchoscopy and post-mortem examination specimens may beobtained from relatives of subjects with familial pulmonary fibrosis or healthy research volunteers. Comparison of specimens from affected patients and healthy research volunteers will further the understanding of the pathogenesis of pulmonary fibrosis. Blood and lung specimens will be examined for genetic, molecular, and cellular abnormalities that may contribute to accumulation of extracellular matrix proteins and pneumocyte proliferation. In addition, genomic DNA will be procured and analyzed to investigate genotype/phenotype correlations.

Observational
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Pulmonary Fibrosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
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  • 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),

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.

Both
18 Years and older
Yes
Contact: Bernadette R Gochuico, M.D. (301) 451-7979 gochuicb@mail.nih.gov
United States
 
NCT00084305
040211, 04-HG-0211
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National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
National Human Genome Research Institute (NHGRI)
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Principal Investigator: Bernadette R Gochuico, M.D. National Human Genome Research Institute (NHGRI)
National Institutes of Health Clinical Center (CC)
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP