NCT02432560 Safety and Durability of Sirolimus for Treatment of LAM
| NCT ID | NCT02432560 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Cincinnati |
| Condition | Lymphangioleiomyomatosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2015-03 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2015-03 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The MIDAS study aims to follow male and female LAM patients who are currently taking, have previously failed or been intolerant of, or may (at some time in the future) take mTOR inhibitors (sirolimus or everolimus) as part of their clinical care. Adult female TSC patients may also enroll, with or without lung cysts.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Inability to attend at least one RLD Clinic visit per year * Inability to give informed consent * Inability or unwillingness to perform pulmonary function testing
Contact & Investigator
Francis X McCormack, MD
STUDY DIRECTOR
University of Cincinnati
Frequently Asked Questions
Who can join the NCT02432560 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Lymphangioleiomyomatosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02432560 currently recruiting?
Yes, NCT02432560 is actively recruiting participants. Contact the research team at susan.mcmahan@uc.edu for enrollment information.
Where is the NCT02432560 trial being conducted?
This trial is being conducted at Stanford, United States, Denver, United States, Jacksonville, United States, Atlanta, United States and 11 additional locations.
Who is sponsoring the NCT02432560 clinical trial?
NCT02432560 is sponsored by University of Cincinnati. The principal investigator is Francis X McCormack, MD at University of Cincinnati. The trial plans to enroll 600 participants.