Safety and Durability of Sirolimus for Treatment of LAM

Part of paid clinical trials in Stanford, California.

Sponsor
University of Cincinnati
Study ID
NCT02432560
Status
Recruiting
Apply to this trial

Conditions

  • Lymphangioleiomyomatosis

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 31, 2015
Status verified
Dec 2024
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Everolimus
    women over age 18 who have LAM and are currently taking, have previously failed or been intolerant of, or who are considering taking everolimus as part of their clinical care
  • Arm: Sirolimus
    women over age 18 who have LAM and are currently taking, have previously failed or been intolerant of, or who are considering taking sirolimus as part of their clinical care

Primary Outcome Measure

Long term safety of mTOR inhibitor treatment in LAM [ Time Frame: 2-5 years ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
Stanford University Medical CenterStanfordCalifornia94305
Stephen Ruoss, MD
[email protected]
650-723-6381
National Jewish HealthDenverColorado80206
Gregory Downey, MD
[email protected]
303-398-1436
Mayo Clinic JacksonvilleJacksonvilleFlorida32224
Charles Burger, MD
[email protected]
904-953-2381
Emory University School of MedicineAtlantaGeorgia33136
Sirhari Veeraraghavan, MD
[email protected]
Loyola University Medical Center, ChicagoMaywoodIllinois60153-
Brigham and Women's HospitalBostonMassachusetts02115
Elizabeth Henske, MD
[email protected]
857-307-0784
University of MichiganAnn ArborMichigan48109
Mei Lan Han, MD
[email protected]
734-936-5047
Mayo Clinic RochesterRochesterMinnesota55905-
Washington University School of MedicineSt LouisMissouri63110
Adrian Shifren, MD
[email protected]
314-362-6904
University of Rochester Medical CenterRochesterNew York14642-8692
MaryAnne Morgan, MD
[email protected]
585-275-4161
University of CincinnatiCincinnatiOhio45267-
Cleveland ClinicClevelandOhio44195-
Oregon Health and Science UniversityPortlandOregon97239-
University of Pennsylvania Medical CenterPhiladelphiaPennsylvania19104-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Vanderbilt University Medical CenterNashvilleTennessee37232-2650-
University of Texas Southwestern Medical CenterDallasTexas75390-
University of Texas Health CenterHoustonTexas77030-
University of Utah School of MedicineSalt Lake CityUtah84132-
Swedish Medical CenterSeattleWashington98104-

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