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

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

Inclusion Criteria4

  • 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 Criteria3

  • Inability to attend at least one RLD Clinic visit per year
  • Inability to give informed consent
  • Inability or unwillingness to perform pulmonary function testing

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