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Official Record of Patients Diagnosed With Lymphangioleiomyomatosis (LAM)

This study has been completed.
Study NCT00001869.   Last updated on March 3, 2008.   Information provided by National Institutes of Health Clinical Center (CC)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Official Record of Patients Diagnosed With Lymphangioleiomyomatosis (LAM)
Official Title  Lymphangioleiomyomatosis (LAM) Registry
Brief Summary

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.

Detailed Description

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.

Study Phase
Study Type  Observational
Study Design 
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Leiomyomatosis
Intervention 
MEDLINE PMIDs 8024411,   2367651,   1000470
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  400
Start Date  December 1998
Completion Date April 2003
Eligibility Criteria 

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.

Gender Both
Ages
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001869
Organization ID 990020
Secondary IDs †† 99-H-0020
Study Sponsor  National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ††
Investigators 
Information Provided By National Institutes of Health Clinical Center (CC)
Verification Date April 2003
First Received Date  November 3, 1999
Last Updated Date March 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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