Lymphangioleiomyomatosis (LAM) Registry - Tabular View

Tracking Information

First Received Date ^ICMJE

May 25, 2000

Last Updated Date

January 3, 2006

Start Date ^ICMJE

July 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00005486 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Lymphangioleiomyomatosis (LAM) Registry

Official Title ^ICMJE

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 Women's Health provided funding in FY 1997 in the amount of $100,000.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Natural History

Condition ^ICMJE

Lung Diseases
Lymphangiomyomatosis

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

No eligibility criteria

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00005486

Responsible Party

Study ID Numbers ^ICMJE

5002

Study Sponsor ^ICMJE

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators ^ICMJE

Investigators ^ICMJE

Investigator:

Gerald Beck

The Cleveland Clinic

Information Provided By

National Heart, Lung, and Blood Institute (NHLBI)

Verification Date

December 2005

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