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Analysis of Specimens From Individuals With Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00084305
Recruitment Status : Recruiting
First Posted : June 10, 2004
Last Update Posted : June 2, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )

Study Description
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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 Healthy Volunteers Hermansky-Pudlak Syndrome (HPS)

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
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Analysis of Specimens From Individuals With Pulmonary Fibrosis
Actual Study Start Date : June 9, 2004

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Family
Family members of patients with pulmonary fibrosis
Healthy Volunteers
Healthy Volunteers
Pulmonary Fibrosis
Patients with pulmonary fibrosis


Outcome Measures
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Primary Outcome Measures :
  1. Procure and analyze [ Time Frame: Ongoing ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with pulmonary fibrosis@@@@@@
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).
Contacts and Locations
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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
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Contact: Wendy J Introne, M.D. (301) 451-8879 wi2p@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Human Genome Research Institute (NHGRI)
Investigators
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Principal Investigator: Wendy J Introne, M.D. National Human Genome Research Institute (NHGRI)
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Human Genome Research Institute (NHGRI)
ClinicalTrials.gov Identifier: NCT00084305    
Other Study ID Numbers: 040211
04-HG-0211
First Posted: June 10, 2004    Key Record Dates
Last Update Posted: June 2, 2023
Last Verified: January 20, 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) ):
Bronchoscopy
Pulmonary Fibrosis
Lung Biopsy (Clinically-Indicated)
Natural History
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Hermanski-Pudlak Syndrome
Fibrosis
Pathologic Processes
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Albinism, Oculocutaneous
Albinism
Eye Diseases, Hereditary
Eye Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
 Hematologic Diseases
Platelet Storage Pool Deficiency
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Skin Diseases, Genetic
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Metabolic Diseases