Trial record 3 of 9 for: "Leiomyomatosis"

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Official Record of Patients Diagnosed With Lymphangioleiomyomatosis (LAM)

This study has been completed.

Sponsor:

Information provided by:

National Institutes of Health Clinical Center (CC)

ClinicalTrials.gov Identifier:

NCT00001869

First received: November 3, 1999

Last updated: March 3, 2008

Last verified: April 2003

History of Changes

Purpose

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.

Condition
Leiomyomatosis


Study Type:	Observational
Official Title:	Lymphangioleiomyomatosis (LAM) Registry

Resource links provided by NLM:

Genetics Home Reference related topics: lymphangioleiomyomatosis

Genetic and Rare Diseases Information Center resources: Lymphangioleiomyomatosis Tuberous Sclerosis Bourneville Syndrome Intravenous Leiomyomatosis

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):


Estimated Enrollment:	400
Study Start Date:	December 1998
Estimated Study Completion Date:	April 2003

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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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;

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

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001869

Locations


United States, Maryland
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

More Information

Publications:

Abdulla M, Bui HX, del Rosario AD, Wolf BC, Ross JS. Renal angiomyolipoma. DNA content and immunohistochemical study of classic and multicentric variants. Arch Pathol Lab Med. 1994 Jul;118(7):735-9.

Aberle DR, Hansell DM, Brown K, Tashkin DP. Lymphangiomyomatosis: CT, chest radiographic, and functional correlations. Radiology. 1990 Aug;176(2):381-7.

Basset F, Soler P, Marsac J, Corrin B. Pulmonary lymphangiomyomatosis: three new cases studied with electron microscopy. Cancer. 1976 Dec;38(6):2357-66.


ClinicalTrials.gov Identifier:	NCT00001869 History of Changes
Other Study ID Numbers:	990020 99-H-0020
Study First Received:	November 3, 1999
Last Updated:	March 3, 2008

Keywords provided by National Institutes of Health Clinical Center (CC):


Progesterone Pulmonary Function Tests Pneumothorax Oopherectomy	High Resolution CT Tuberous Sclerosis Complex Lymphangioleiomyomatosis (LAM)

Additional relevant MeSH terms:


Leiomyomatosis Lymphangioleiomyomatosis Lymphangiomyoma Lymphatic Vessel Tumors Neoplasms by Histologic Type Neoplasms Perivascular Epithelioid Cell Neoplasms	Neoplasms, Connective and Soft Tissue Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leiomyoma Neoplasms, Muscle Tissue

ClinicalTrials.gov processed this record on July 14, 2017

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