Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005317
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
2000-05-25
Brief Title:
Idiopathic Pulmonary Fibrosis--Pathogenesis and Staging - SCOR in Occupational and Immunological Lung Diseases
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To conduct cross-sectional and longitudinal studies of patients with idiopathic pulmonary fibrosis IPF and patients with progressive systemic sclerosis PSS with and without associated lung disease
Detailed Description:
BACKGROUND
Idiopathic pulmonary fibrosis IPF is a disease of unknown etiology characterized pathologically by a chronic inflammatory process alveolitis that precedes and likely controls the alterations in connective tissue matrix that eventually destroys the normal lung architecture The mechanisms involved in this process are not known A complex cell-cell interactive sequence involving principally neutrophils lymphocytes macrophages fibroblast and epithelial cells is believed to be responsible
The SCOR in Occupational and Immunological Lung Diseases was first awarded in December 1981 The subproject on idiopathic pulmonary fibrosis was first awarded in December 1986
DESIGN NARRATIVE
The cross-sectional comparison examined bronchoalveolar lavage high resolution thin-section computer tomography HRCT neutrophil or monocyte labeled scintigraphy The serial longitudinal evaluation monitored the progression of disease The study of PSS patients without disease or with subclinical disease was particularly useful because it allowed examination of the early events in the pathogenesis of IPF The long-term goal of the project was to determine what alterations in cellular composition function and trafficking occurred in the lung parenchyma of patients with IPF and to relate these alterations to the disease stage prognosis and therapeutic responsiveness
The major objectives of the study were 1 to continue the prospective longitudinal study of carefully defined cases of IPF 2 to initiate a study of patients with PSS a disease that provided a useful paradigm for studying the early events of the disease 3 to determine the role of the lymphocyte in IPF by defining the subset of T lymphocytes responsible for modulating macrophage function 4 to establish the role of non-invasive techniques bronchoalveolar lavage BAL HRCT scanning and scintigraphy -- neutrophil and monocyte labelled cells in assessing the activity of inflammation in carefully evaluated patients 5 to determine the relationship of these results to the -- carefully defined and serially obtained -- clinical radiographical and physiological findings and to the histopathologic abnormalities in patients that underwent lung biopsy predominantly IPF cases 6 to perform studies utilizing blood BAL fluid and lung tissue in an effort to understand the pathogenic mechanisms that underlied the inflammatoryimmune cellular injury and fibrosis that characterize this disease
The study completion date listed in this record was obtained from the Completed Date entered in the Query View Report System QVR
Idiopathic pulmonary fibrosis IPF is a disease of unknown etiology characterized pathologically by a chronic inflammatory process alveolitis that precedes and likely controls the alterations in connective tissue matrix that eventually destroys the normal lung architecture The mechanisms involved in this process are not known A complex cell-cell interactive sequence involving principally neutrophils lymphocytes macrophages fibroblast and epithelial cells is believed to be responsible
The SCOR in Occupational and Immunological Lung Diseases was first awarded in December 1981 The subproject on idiopathic pulmonary fibrosis was first awarded in December 1986
DESIGN NARRATIVE
The cross-sectional comparison examined bronchoalveolar lavage high resolution thin-section computer tomography HRCT neutrophil or monocyte labeled scintigraphy The serial longitudinal evaluation monitored the progression of disease The study of PSS patients without disease or with subclinical disease was particularly useful because it allowed examination of the early events in the pathogenesis of IPF The long-term goal of the project was to determine what alterations in cellular composition function and trafficking occurred in the lung parenchyma of patients with IPF and to relate these alterations to the disease stage prognosis and therapeutic responsiveness
The major objectives of the study were 1 to continue the prospective longitudinal study of carefully defined cases of IPF 2 to initiate a study of patients with PSS a disease that provided a useful paradigm for studying the early events of the disease 3 to determine the role of the lymphocyte in IPF by defining the subset of T lymphocytes responsible for modulating macrophage function 4 to establish the role of non-invasive techniques bronchoalveolar lavage BAL HRCT scanning and scintigraphy -- neutrophil and monocyte labelled cells in assessing the activity of inflammation in carefully evaluated patients 5 to determine the relationship of these results to the -- carefully defined and serially obtained -- clinical radiographical and physiological findings and to the histopathologic abnormalities in patients that underwent lung biopsy predominantly IPF cases 6 to perform studies utilizing blood BAL fluid and lung tissue in an effort to understand the pathogenic mechanisms that underlied the inflammatoryimmune cellular injury and fibrosis that characterize this disease
The study completion date listed in this record was obtained from the Completed Date entered in the Query View Report System QVR
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: