RECRUITING

Safety and Durability of Sirolimus for Treatment of LAM

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Conditions

LymphangioleiomyomatosisLAMrare lungRare Lung Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2015-03
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02432560

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female or male, age 18 or over
  2. * Diagnosis of LAM based on ATS/JRS criteria
  3. * Signed and dated informed consent
  4. * On chronic therapy, newly treated or may be considered for therapy with mTOR inhibitors or previously intolerant of or having failed mTOR inhibitor therapy
  1. * Inability to attend at least one RLD Clinic visit per year
  2. * Inability to give informed consent
  3. * Inability or unwillingness to perform pulmonary function testing

Contacts and Locations

Study Contact

Susan McMahan Sellers, BSN, RN
CONTACT
(513) 558-4376
susan.mcmahan@uc.edu
Francis X McCormack, MD
CONTACT
(513) 558-0588
frank.mccormack@uc.edu

Principal Investigator

Francis X McCormack, MD
STUDY_DIRECTOR
University of Cincinnati

Study Locations (Sites)

Stanford University Medical Center
Stanford, California, 94305
United States
National Jewish Health
Denver, Colorado, 80206
United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
United States
Emory University School of Medicine
Atlanta, Georgia, 33136
United States
Loyola University Medical Center, Chicago
Maywood, Illinois, 60153
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
University of Rochester Medical Center
Rochester, New York, 14642-8692
United States
University of Cincinnati
Cincinnati, Ohio, 45267
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2650
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
University of Texas Health Center
Houston, Texas, 77030
United States
University of Utah School of Medicine
Salt Lake City, Utah, 84132
United States
Swedish Medical Center
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: University of Cincinnati

  • Francis X McCormack, MD, STUDY_DIRECTOR, University of Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-03
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2015-03
Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

  • Lymphangioleiomyomatosis
  • LAM
  • rare lung
  • Rare Lung Disease

Additional Relevant MeSH Terms

  • Lymphangioleiomyomatosis