This study is accepting new patients by invitation only

Ascertaining Longterm Outcomes of Fibroid Treatments

a study on Uterine Fibroids

Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

The goal of the ALOFT study is to understand the health of women in the 12 years following a uterine fibroid (UF) treatment. ALOFT is a multi-center, prospective, observational cohort study of approximately 700 women who have undergone uterine-sparing treatment procedures for UF and previously participated in the longitudinal studies COMPARE-UF (NCT02260752) or ULTRA (NCT02100904).

The primary uterine sparing treatment procedures undergone by study participants are myomectomy, endometrial ablation (EA), uterine artery embolization (UAE) and laparoscopic radiofrequency ablation (RFA). A smaller number of women may be studied who underwent focused ultrasound, intrauterine device (IUD), and medical management.

Two follow-up study contacts with COMPARE-UF and ULTRA participants will occur to assess changes in UF symptoms and treatment failure which is defined as the need for another UF treatment procedure. Questionnaires will be used to collect data on patient-reported characteristics and outcomes and quality of life.

The study's analyses will focus on comparisons of primary and secondary outcomes among women.

Official Title

Long Term Effectiveness of Uterine Sparing Fibroid Treatments

Keywords

Uterine Fibroid, Uterine fibroid treatment, Multi-center, prospective, observational cohort study, Uterine-sparing treatment procedures, Patient-reported outcomes, Quality of life, Leiomyoma, Myofibroma

Eligibility

You can join if…

Open to females ages 18 years and up

  • Participant has to have been enrolled in either the COMPARE-UF or ULTRA study
  • Participant had a uterine-sparing fibroid treatment at enrollment in COMPARE-UF or ULTRA study

You CAN'T join if...

  • Individuals who were not consented into the original COMPARE-UF or ULTRA study
  • Individuals who did not have a uterine-sparing fibroid treatment at enrollment in COMPARE-UF or ULTRA study

Locations

  • UCSF
    San Francisco California 94143 United States
  • Mayo Clinic
    Rochester Minnesota 55905 United States
  • Henry Ford Health
    Detroit Michigan 48202 United States
  • The University of North Carolina at Chapel Hill
    Chapel Hill North Carolina 27514 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Henry Ford Health System
Links
ALOFT study landing page
ID
NCT06430320
Study Type
Observational
Participants
Expecting 700 study participants
Last Updated