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Official Record of Patients Diagnosed With Lymphangioleiomyomatosis (LAM)
This study has been completed.
Study NCT00001869   Information provided by National Institutes of Health Clinical Center (CC)
First Received: November 3, 1999   Last Updated: March 3, 2008   History of Changes

November 3, 1999
March 3, 2008
December 1998
 
 
 
Complete list of historical versions of study NCT00001869 on ClinicalTrials.gov Archive Site
 
 
 
Official Record of Patients Diagnosed With Lymphangioleiomyomatosis (LAM)
Lymphangioleiomyomatosis (LAM) Registry

Pulmonary lymphoangioleiomyomatosis (LAM) is a rare destructive lung disease typically affecting women of childbearing age. Currently, there is no effective therapy for the disease and the prognosis is poor.

In order to better study this disease, the National Heart, Lung, and Blood Institute (NHLBI) has developed a registry to keep an official record of patients diagnosed with LAM. This research project will collect data from 6 health care centers as well as outside physicians. Researchers hope to provide valuable information about the rate of lung destruction and quality of life in patients with LAM.

Patients participating in this study will be followed for 5 years. Tissue collected from these patients may contribute to the development of future studies on the disease processes of LAM.

LAM is a rare disease that predominantly affects women of child-bearing age. To study in more detail this rare disease, this multi-center project will establish a registry of persons with LAM. By combining data from 6 centers and outside physicians, this study may yield valuable information regarding the rate of decline in pulmonary function and quality of life in individuals with LAM. These patients will be followed over a five-year period. Tissue collected from study participants may facilitate future studies into the molecular basis of LAM.

 
Observational
 
Leiomyomatosis
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
400
April 2003
 

Informed consent must be obtained from the patient.

Patients must be female.

Patients must be age 18 or older.

Patients with prevalent and incident cases are eligible.

Patients with the presence or absence of underlying diagnosis or evidence of Tuberous Sclerosis Complex (TSC) are eligible.

Patients must have a diagnosis of LAM confirmed by any of the following criteria:

Lung biopsy (transbronchial, surgical, transthoracic) judged to be diagnostic by the Tissue Core pathologists;

OR

Biopsy of lymph node or other mass judged to be diagnostic by the Tissue Core pathologists;

OR

High resolution CT scan of the chest which is judged to be diagnostic of LAM with a high degree of certainty by all three of the expert radiologists making up the Imaging Core.

Patients may be enrolled in other protocols.

Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001869
 
990020, 99-H-0020
National Heart, Lung, and Blood Institute (NHLBI)
 
 
National Institutes of Health Clinical Center (CC)
April 2003

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