Ascertaining Longterm Outcomes of Fibroid Treatments

NCT06430320 | Enrolling By Invitation

• 1 other identifier: R9NXPE2GTCN9
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Uterine Fibroid

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time to treatment failure

  The need for another uterine fibroid treatment procedure

  Up to 12 years

Interventions

NA- no intervention OTHER

NA- no intervention

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who were previously enrolled in either the COMPARE-UF or ULTRA study

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• Henry Ford Health System: lead
• Mayo Clinic: collaborator
• University of California, San Francisco: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (4)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Links

• ALOFT study landing page

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Ganesa Wegienka, PhD

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: May 20, 2024
• Primary Completion: March 31, 2025
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)