Actively Recruiting
Multicenter International Durability and Safety of Sirolimus in LAM Trial (MIDAS)
Led by University of Cincinnati · Updated on 2024-12-24
600
Participants Needed
20
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Cincinnati
Lead Sponsor
R
Rare Diseases Clinical Research Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
Lymphangioleiomyomatosis (LAM) is a rare lung disease that mainly affects women and causes lung cysts and progressive breathing problems. Researchers are studying the long-term safety and effects of mTOR inhibitors, specifically sirolimus and everolimus, in treating LAM. This observational study aims to follow patients who are currently using, have previously stopped, or may start these treatments as part of their medical care. The study is conducted by the University of Cincinnati and supported by the NIH Rare Lung Disease Consortium. Participants include women and men aged 18 or older with LAM, who are on chronic mTOR inhibitor therapy, newly treated, or may be considered for treatment. The study tracks patients receiving sirolimus or everolimus as prescribed by their doctors, without assigning treatments. It observes real-world use of these drugs over several years, focusing on safety and lung function. During the study, researchers will collect lung function tests and monitor adverse events for at least 2 years, with some outcomes followed up to 5 years. Patients will be seen at least once per year at a Rare Lung Disease Clinic, and pulmonary function testing will be performed. The main outcomes measured are the safety of long-term mTOR inhibitor use and changes in lung function, including forced expiratory volume (FEV1). Quality of life will also be evaluated. Participation requires informed consent and willingness to attend clinic visits and perform lung tests.
CONDITIONS
Brief Title
Safety and Durability of Sirolimus for Treatment of LAM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male, age 18 or over
- Diagnosis of LAM based on ATS/JRS criteria
- Signed and dated informed consent
- On chronic therapy, newly treated or may be considered for therapy with mTOR inhibitors or previously intolerant of or having failed mTOR inhibitor therapy
You will not qualify if you...
- Inability to attend at least one RLD Clinic visit per year
- Inability to give informed consent
- Inability or unwillingness to perform pulmonary function testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 2 years
Participants who are on, have previously failed or been intolerant of, or are considering mTOR inhibitor therapy for LAM are observed over time with periodic lung function tests and adverse event assessments as part of their clinical care.
At least 1 visit per year
Trial Site Locations
Total: 20 locations
1
Stanford University Medical Center
Stanford, California, United States, 94305
Actively Recruiting
2
National Jewish Health
Denver, Colorado, United States, 80206
Actively Recruiting
3
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
4
Emory University School of Medicine
Atlanta, Georgia, United States, 33136
Actively Recruiting
5
Loyola University Medical Center, Chicago
Maywood, Illinois, United States, 60153
Active, Not Recruiting
6
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
7
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
8
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Active, Not Recruiting
9
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
10
University of Rochester Medical Center
Rochester, New York, United States, 14642-8692
Actively Recruiting
11
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Active, Not Recruiting
12
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Active, Not Recruiting
13
Oregon Health and Science University
Portland, Oregon, United States, 97239
Active, Not Recruiting
14
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Active, Not Recruiting
15
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Active, Not Recruiting
16
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2650
Active, Not Recruiting
17
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Active, Not Recruiting
18
University of Texas Health Center
Houston, Texas, United States, 77030
Active, Not Recruiting
19
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
Active, Not Recruiting
20
Swedish Medical Center
Seattle, Washington, United States, 98104
Active, Not Recruiting
Research Team
S
Susan McMahan Sellers, BSN, RN
F
Francis X McCormack, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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