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NCT06430320 Clinical Trial

Ascertaining Longterm Outcomes of Fibroid Treatments

Uterine Fibroid Clinical Trial

— ALOFT  

Official title:
Long Term Effectiveness of Uterine Sparing Fibroid Treatments

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06430320
Other study ID # R9NXPE2GTCN9
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 20, 2024
Est. completion date August 2027

Study information
Verified date May 2024
Source Henry Ford Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 700
Est. completion date August 2027
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• NA- no intervention
NA- no intervention

Locations
Country Name City State
United States The University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Henry Ford Health Detroit Michigan
United States Mayo Clinic Rochester Minnesota
United States University of California San Francisco San Francisco California

Sponsors (4)
Lead Sponsor Collaborator
Henry Ford Health System Mayo Clinic, University of California, San Francisco, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to treatment failure The need for another uterine fibroid treatment procedure Up to 12 years
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Not yet recruiting NCT05840042 - Epidemiology and Risk Factors of Uterine Fibroids in China
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