Current Clinical Trials and Studies
A major part of The LAM Foundation’s mission is supporting promising research that leads to an improved understanding of LAM and helps develop novel treatment options. Patient engagement is essential to fully powering LAM clinical trials and studies. Below you will find a list of research studies and trials that are currently enrolling. Please contact study team coordinators to learn more.
Tissue Donation – National Disease Research Interchange (NDRI)
National Disease Research Interchange (NDRI) NDRI’s Private Donor Program gives individuals and their families an opportunity to provide an invaluable resource for researchers working to discover and advance new treatments or cures. A variety of tissue samples from women with LAM, including lung, kidney, uterus, blood and chyle fluid are currently needed by LAM researchers.
Contact info:
If you are having surgery and would be willing to make a tissue donation or would like to learn more about the tissue donation process, please contact Patient Services at patientservices@thelamfoundation.org or (513) 777-6889.
Respiratory Oscillometry for Lung Function Monitoring in Lymphangioleiomyomatosis
Chung-Wai Chow MD, PhD, FRCPC, University Health Network
We are looking for participants with LAM to participate in a research study being conducted at Toronto General Hospital, Ontario, Canada. The study aims to test the lung function of LAM patients using a device called oscillometry, standard pulmonary function tests and computed tomography (CT) scans. Oscillometry has been shown to be more sensitive to changes in the small airways and is done during normal breathing. The study visit will involve the following:
- You will have oscillometry breathing test done
- You will have the standard pulmonary function tests done with optional bronchodilator testing using Ventolin or Salbutamol
- You will have optional CT scan done
- You will complete two questionnaires: Medical Health Questionnaire and Study Comparison Questionnaire
Participants who are interested are asked to contact the research team using the below email or phone number, and the study team will have a call with you determine whether you would be eligible for the study before bringing you in-person to Toronto General Hospital, Toronto, Ontario. If not eligible, any collected information will be destroyed.
Reimbursement:
You will be compensated for your participation in the study.
Contact Info:
For more information or to participate, please contact the study team:
LungFunctionStudies@uhn.ca
647-640-8106
Study Site:
Toronto General Hospital, 585 University Ave, Toronto, ON, Canada, M5G 2N2
Menstrual Variation in LAM
Principal Investigator: Nishant Gupta, MD at the University of Cincinnati
We are seeking premenopausal women with LAM who are not currently taking hormonal birth control to participate in a seven-month observation study. Our goal is to evaluate the impact of hormonal fluctuations that occur during the menstrual cycle on LAM symptoms and lung function decline. While all LAM patients are eligible for the study, we have limited spots left open for patients who are on sirolimus. As a reminder, the entire study is remote, there is no travel required, and you do not need to have cyclical symptom variability to be in the study. In fact, patients with LAM not on sirolimus and not experiencing clinical symptom variability is the largest subgroup that we need to recruit.
Brief study description: Participants will receive a small home spirometer and ovulation test kits at no cost. You will be asked to keep a calendar of your menstrual cycle for about 7 menstrual cycles. During this time, you will perform home spirometry and complete a short symptom and quality of life questionnaire twice a week.
To get more information or to enroll in the study, please contact the lead study coordinator, Emillie Hoh at hohek@ucmail.uc.edu
LAM Patient Needs Assessment and Research Priorities Survey (LAM PREP)
The LAM Foundation seeks to better understand LAM patients’ health needs and research priorities. The LAM Patient Needs Assessment, and Research Priorities Survey (LAM-PREP) will allow the LAM Foundation (The LAM Foundation) to support scientific projects that can maximally benefit LAM patients and compare them to the scientific and research priorities of LAM professionals and The LAM Foundation. This organized, formal, and systematic approach will guide the development and implementation a comprehensive plan for LAM research priorities to allocate resources and improve the health outcomes of those affected by LAM.
LAM community participation occurred between June and December 2023 via focus groups and an online survey will be released in March 2024. Information will be forthcoming via email and social media.
Contact info:
Contact The LAM Foundation at patientservices@thelamfoundation.org or call 513-777-6889 for more information.
NIH/NHLBI Trials:
Discovery of Sirolimus Sensitive Biomarkers in Blood
- NHLBI Protocol number: 18-H-0003
- Joel Moss, MD, PhD, National Institutes of Health
This study is an observational study designed to determine if blood and urine markers after 1 dose and again after 3 months can be used to evaluate the correct dose of sirolimus for people with LAM. Women ages 18-90 with LAM whose doctors have decided they should start taking a 2 mg dose of sirolimus to treat it and who are able to travel to NIH are eligible to participate.
Pathogenesis of Lymphangioleiomyomatosis (LAM)
- NHLBI Protocol number: 95-H-1086
- Joel Moss, MD, PhD, National Institutes of Health
This study is looking at the relationship between lymphatic disorders and gene variations found in the lungs, blood, and other parts of the body. Researchers hope this will improve our understanding of these types of disorders and how genetic factors affect them. Adult women and men with confirmed LAM and a diagnosis of TSC-LAM or Sporadic LAM are eligible.
Cutaneous Tumorigenesis in Patients with Tuberous Sclerosis
- NHLBI Protocol number: 00-H-0051
- Joel Moss, MD, PhD, National Institutes of Health
This study is investigating what causes multiple skin tumors to develop in people with tuberous sclerosis. To participate in the study, you must an adult woman or man, with definite or possible TSC, based on clinical and/or genetic criteria.
Genetic Factors in the Pathogenesis of Lung Disease
- NHLBI Protocol number: 96-H-0100
- Joel Moss, MD, PhD, National Institutes of Health
This study will investigate the genes involved in the breathing process and in the development of lung diseases such as asthma or sarcoidosis to improve understanding of the role they play. Adult women and men with lung disease (includes healthy volunteers) are eligible.
Bronchodilator Effects of Nebulized Versus Inhaled Albuterol in Subjects With Lymphangioleiomyomatosis
- NHLBI Protocol number: 13-H-0051
- Joel Moss, MD, PhD, National Institutes of Health
LAM is a progressive lung disease that usually strikes women during their childbearing years, usually between the onset of puberty and menopause. Doctors at the National Institutes of Health (NIH) are conducting a research study to compare two methods, albuterol (study drug) given in metered dose inhaler and sprayer, and to determine which of these two methods best improves lung function in women with LAM. Adult women who have impaired lung function because of LAM are eligible.
For all NIH/NHLBI trials:
If you are interested in learning more, please contact:
Tat’Yana Worthy, RN, MSN
Research Nurse Specialist, National Institutes of Health
(301)-496-3632 (o)
TAT’YANA WORTHY, RN MSNStudy site: Bethesda, MD
Visit https://go.usa.gov/xuuz9 for more details.