We are seeking participants for a Lymphangioleiomyomatosis (LAM) research study. To qualify, you must meet one of the following requirements:
1. You are a female who has been diagnosed with LAM
2. You are a female who will serve as a control subject - someone who does not have a known lung disease, or who has a known lung disease that is not LAM
Lymphangioleiomyomatosis (lim-FAN-jee-o-LYE-o-MY-o-ma-TOE-sis) is a rare, fatal, multi-system disease affecting women in their childbearing years. LAM causes destruction throughout the body, often in the lungs, kidneys and lymphatics. This destruction is attributed to migration, clustering, cell signaling and cell-other cell-cell “LAM cell” abnormalities. Over time, patients may progress to respiratory failure as cysts and nodules take over normal lung. There is no known cure or treatment, and the mechanisms of destruction of lung and other tissues in LAM are poorly understood. LAM affects women of all races, nations and economic backgrounds. Between 30,000 and 50,000 women worldwide are estimated to have sporadic pulmonary LAM. Approximately 250,000 women worldwide have the form of LAM linked to a genetic disorder called Tuberous Sclerosis Complex (TSC). LAM is understood to be more sex-specific than breast cancer.
Our Research Study
In a disease that is understood to be more sex-specific than breast cancer, it is remarkable that no broad-based clinical study that we know of has attempted to look at hormone levels in women with LAM and the possible relationship between these and cyclical breathing symptoms or pulmonary decline. Without minimizing the complexity of this type of investigation, the LAM Treatment Alliance ("LTA") is committed to addressing overlooked areas in innovative ways by leveraging leading-edge technology to keep inquiry rigorous, cost effective and quick. The LTA is especially eager to draw on patients' willingness and ability to accelerate research through knowledge of their most precious asset - their bodies. We are grateful for your time and willingness to consider participating in this pilot study.
We are performing this exploratory pilot study to determine if there is measurable and significant short-term variability in dyspnea (breathlessness) and pulmonary function in LAM patients and whether observed variability in this can be further associated with the menstrual cycle. This study was motivated by numerous patient anecdotes and questions about variation in breathlessness that some patients believe may be associated with their menstrual cycle. Existing clinical data collected from LAM patients does not provide sufficient insight into short-term changes in breathlessness. This makes it difficult for researchers to validate anecdotes about cyclical changes in breathing. More data on this topic will provide insights to clinicians and researchers about the role estrogen and/or progesterone may play in LAM. This may affect the course of future research into potential treatments or cures
This study is being directed by Frank Moss and Ian Eslick from the MIT Media Lab at the Massachusetts Institute of Technology (MIT), in collaboration with the LTA on behalf of the global LAM community. It has been created with input from those with expertise in dyspnea and in LAM. The study is being conducted through the LAMsight web portal, funded and supported by the LTA. The LTA is committed to fostering transparent collaboration between patients, researchers and clinicians. LAMsight enables LAM patients to contribute to research in a new and easy way, which gives LAM researchers real-time ongoing access to critical data from the global LAM patient population. We invite you to get involved and spread the word!
Participants will record daily measurements of pulmonary function, ovulation, and dyspnea over a three to five month period. Pulmonary function will be measured by a home spirometer. Ovulation will be measured through the use of an ovulation kit. All materials for the study have been funded by the LTA and will be provided at no cost to participants. For a more detailed explanation of the study design and requirements, please visit: http://www.LAMsight.org/est-public-intro
We anticipate the study to be fully enrolled by September 3, 2012.
At approximately three months from that date, a preliminary review will be completed to determine if data collected to that point is sufficient for a full analysis. Depending on the preliminary data review, the study will be complete at that time or continue for another two months. Within one month of the end of the study, data will be analyzed and a report will be produced. A link to study results will be posted on LAMsight and distributed to all study participants. All data will be fully de-identified, reported in aggregate form, and available to researchers throughout the world upon request
If you know of someone who might be willing to participate in the study, ask them to contact us at: EstrogenStudy@LAMTreatmentAlliance.org
You can register for the study by first logging into your existing LAMsight account and then clicking on the following link:http://www.LAMsight.org?action=estrogen-study-signup
Questions? mail to: EstrogenStudy@LAMTreatmentAlliance.org or mail to: firstname.lastname@example.org or email@example.com