RecruitingNCT02432560

Safety and Durability of Sirolimus for Treatment of LAM

Multicenter International Durability and Safety of Sirolimus in LAM Trial (MIDAS)

Sponsor

University of Cincinnati

Enrollment

600 participants

Start Date

Mar 1, 2015

Study Type

OBSERVATIONAL

Conditions

Lymphangioleiomyomatosis

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking the long-term safety and effectiveness of sirolimus (rapamycin) — a drug that slows abnormal cell growth in the lungs — in patients with a rare lung disease called lymphangioleiomyomatosis (LAM), where abnormal cells slowly destroy lung tissue over time. **You may be eligible if...** - You are 18 years of age or older - You have been diagnosed with LAM based on accepted medical criteria - You are currently on, starting, or have previously tried a drug in the same family as sirolimus (called mTOR inhibitors) - You are able to give informed consent **You may NOT be eligible if...** - You are unable to visit the clinic at least once a year - You are unable to give informed consent - You are unable or unwilling to do standard breathing tests Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSirolimus

Sirolimus treatment will be part of a participant's clinical care and will be managed by their physician.

DRUGEverolimus

Everolimus treatment will be part of a participant's clinical care and will be managed by their physician.

Locations(20)

Stanford University Medical Center

Stanford, California, United States

National Jewish Health

Denver, Colorado, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Loyola University Medical Center, Chicago

Maywood, Illinois, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Rochester Medical Center

Rochester, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Texas Health Center

Houston, Texas, United States

University of Utah School of Medicine

Salt Lake City, Utah, United States

Swedish Medical Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT02432560

Related Trials

Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis

NCT017995381 location

Study of the Disease Process of Lymphangioleiomyomatosis

NCT000014651 location

Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry (TSC-LAM Registry)

NCT061603101 location

Evaluating the Long-term Safety and Tolerability of Imatinib in Patients With Lymphangioleiomyomatosis (LAM)

NCT068891682 locations

TSC Biosample Repository and Natural History Database

NCT0567609924 locations