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Home > "S" Clinical Trials Conditions > Study of the Disease Process of Lymphangioleiomyomatosis  Study of the Disease Process of Lymphangioleiomyomatosis
Study of the Disease Process of Lymphangioleiomyomatosis
For Condition: Leiomyomatosis,Lung Disease,Pneumothorax,Tuberous Sclerosis
Status: Recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: Pulmonary lymphoangioleiomyomatosis (LAM) is a destructive lung disease typically affecting women of childbearing age. Currently, there is no effective therapy for the disease and the prognosis is poor. This study is designed to determine the disease processes involved at the level of cells and molecules, in order to develop more effective therapy. Researchers plan to identify the proteins and factors that contribute to lung destruction by using bronchoalveolar lavage and lung biopsy to collect samples from the involved lung.
Details: Individuals with pulmonary lymphangioleiomyomatosis develop severe destructive lung disease. Most of them are females of childbearing age. Currently, there is no effective therapy and the prognosis is poor. This study is designed to (a) define the clinical course of the disease and (b) elucidate the pathogenesis of the disease at the cellular and molecular levels, in order to develop more effective therapy. To accomplish this, we intend to identify the proteins and genes that contribute to the process of lung destruction in affected individuals.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: General admission criteria for patients include one or both of the following: Findings on lung biopsy diagnostic of LAM; Findings on chest x-ray and/or chest computed axial tomography consistent with LAM. Patients with TSC and pulmonary LAM will be included in the study. Normal non-smokers in the control group are defined as individuals who have not smoked for greater than or equal to 1 year and have no systemic or pulmonary disease. Normal smokers defined as individuals with no systemic or pulmonary disease, who have smoked for greater than or equal to 1 year and have normal chest x-ray and normal pulmonary function tests may be included if needed as controls for a similar population of patients with LAM. EXCLUSION CRITERIA: Exclusion criteria for patients and normal volunteers include: Age less than 18. Advanced stage of a pulmonary or a systemic illness in which the risk of the study is judged to be significant even in the absence of a clear contraindication to the procedures. Individuals who are taking birth control pills will not be excluded.
Total Enrollment: 999
Location and Contact Information:
National Heart, Lung and Blood Institute (NHLBI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 950186; 95-H-0186
Study Start Date: September 25, 1995
Record last reviewed: July 21, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001465
Other Lung Disease Studies:
1. Study of the Disease Process of Lymphangioleiomyomatosis
2. Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
3. Official Record of Patients Diagnosed with Lymphangioleiomyomatosis (LAM)
Related Studies:
Other Lung Disease Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Study of the Disease Process of Lymphangioleiomyomatosis
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