Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005486
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Lymphangioleiomyomatosis LAM Registry
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:
2005-12
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 establish a registry of individuals with LAM by forming a consortium of six clinical centers and referring physicians who treat LAM patients
Detailed Description:
BACKGROUND
LAM is a rare multi-system disease that can affect the lungs of young women is of uncertain cause is usually progressive and can cause debilitating lung disease which may be corrected with lung transplantation Several hundred women with the disease have been identified largely through a LAM Foundation in Cincinnati Ohio
DESIGN NARRATIVE
The Data and Coordinating Center is located at the Cleveland Clinic Foundation The registry has six major clinical centers Cleveland Clinic Foundation Mayo Clinic-Rochester National Heart Lung and Blood Institute National Jewish Medical and Research Center New England Medical Center and Stanford University Medical Center Data and lung tissue collected by the registry will be used to characterize the clinical features and natural history of the disease and to determine the efficacy of lung transplantation in this disorder Eligible patients are to be seen yearly for up to 4 years at the Clinical Centers or in some cases by individual referring physicians Tissue collected by the LAM Registry will be stored at a central NHLBI repository Outcome events include measures of pulmonary function eg spirometry and when available lung volumes and diffusing capacity arterial blood gases or oximetry walking and resting oxygen titration cardiopulmonary stress testing cause-specific mortality functional status and clinical events associated with lung transplantation
The Office of Research on Womens Health provided funding in FY 1997 in the amount of 100000
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
LAM is a rare multi-system disease that can affect the lungs of young women is of uncertain cause is usually progressive and can cause debilitating lung disease which may be corrected with lung transplantation Several hundred women with the disease have been identified largely through a LAM Foundation in Cincinnati Ohio
DESIGN NARRATIVE
The Data and Coordinating Center is located at the Cleveland Clinic Foundation The registry has six major clinical centers Cleveland Clinic Foundation Mayo Clinic-Rochester National Heart Lung and Blood Institute National Jewish Medical and Research Center New England Medical Center and Stanford University Medical Center Data and lung tissue collected by the registry will be used to characterize the clinical features and natural history of the disease and to determine the efficacy of lung transplantation in this disorder Eligible patients are to be seen yearly for up to 4 years at the Clinical Centers or in some cases by individual referring physicians Tissue collected by the LAM Registry will be stored at a central NHLBI repository Outcome events include measures of pulmonary function eg spirometry and when available lung volumes and diffusing capacity arterial blood gases or oximetry walking and resting oxygen titration cardiopulmonary stress testing cause-specific mortality functional status and clinical events associated with lung transplantation
The Office of Research on Womens Health provided funding in FY 1997 in the amount of 100000
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL058440 | NIH | None | httpsreporternihgovquickSearchU01HL058440 |