Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001532
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
1999-11-03
Brief Title:
Role of Genetic Factors in the Development of Lung Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Role of Genetic Factors in the Pathogenesis of Lung Disease
Status:
RECRUITING
Status Verified Date:
2024-09-05
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:
This study is designed to evaluate the genetics involved in the development of lung disease by surveying genes involved in the process of breathing and examining the genes in lung cells of patients with lung disease
The study will focus on defining the distribution of abnormal genes responsible for processes directly involved in different diseases affecting the lungs of patients and healthy volunteers
Optional CT Sub-study
The standard CT scan will be compared to the low dose radiation CT scan for the 150 subjects enrolled in the sub-study to assess the variation between the two techniques Specifically the quantitative computer aided detection of lung CT abnormalities from LAM can be compared to assess whether low radiation dose CT exams is an alternative to conventional CT to monitor disease
status
This optional sub-study will be offered to up to 100 adult subjects with lung disease and up to 50 children age 9 and older with CF Children will not be enrolled in the optional CT sub-study unless they have had a standard CT scan for medical purposes to use in comparison One additional low dose radiation CT scan of the chest may be done as part of this sub-study when these subjects have their next annual CT scan
The study will focus on defining the distribution of abnormal genes responsible for processes directly involved in different diseases affecting the lungs of patients and healthy volunteers
Optional CT Sub-study
The standard CT scan will be compared to the low dose radiation CT scan for the 150 subjects enrolled in the sub-study to assess the variation between the two techniques Specifically the quantitative computer aided detection of lung CT abnormalities from LAM can be compared to assess whether low radiation dose CT exams is an alternative to conventional CT to monitor disease
status
This optional sub-study will be offered to up to 100 adult subjects with lung disease and up to 50 children age 9 and older with CF Children will not be enrolled in the optional CT sub-study unless they have had a standard CT scan for medical purposes to use in comparison One additional low dose radiation CT scan of the chest may be done as part of this sub-study when these subjects have their next annual CT scan
Detailed Description:
This study is designed to evaluate genetic mechanisms of lung disease by surveying polymorphic genes involved in respiratory function and examining gene expression in the lung cells of individuals with pulmonary disease eg alpha 1-antitrypsin deficiency asthma chronic obstructive pulmonary disease cystic fibrosis sarcoidosis history of infection and genetic mutations consistent with lung pathology Emphasis will be on defining the distribution of allelic variants of nitric oxide synthase alpha 1-antitrypsin and the cystic fibrosis transmembrane conductance regulator genes in patients and in age- and sex-matched healthy individuals in a control population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 96-H-0100 | None | None | None |