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NCT Number: NCT06430320

Ascertaining Longterm Outcomes of Fibroid Treatments

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Uterine Fibroid Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California San Francisco, San Francisco, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NA- no intervention

Other

NA- no intervention

Primary outcomes

  1. Time to treatment failure

    Time frame: Up to 12 years

    The need for another uterine fibroid treatment procedure

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • Mayo Clinic
  • University of California, San Francisco
  • University of North Carolina, Chapel Hill

Registry information

Official study title

Long Term Effectiveness of Uterine Sparing Fibroid Treatments

Acronym: ALOFT

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
May 28, 2024
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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