Ascertaining Longterm Outcomes of Fibroid Treatments

Launched by HENRY FORD HEALTH SYSTEM · May 21, 2024

Keywords

ClinConnect Summary

ALOFT is a long-term observational study looking at how women do in the 12 years after choosing a uterine-sparing treatment for fibroids (treatments that save the uterus). It includes about 700 women at several centers who had such treatments like myomectomy, endometrial ablation, uterine artery embolization, or laparoscopic radiofrequency ablation. Some participants may have had other options as well. The study will check in with participants two times after existing studies (COMPARE-UF or ULTRA) to see how fibroid symptoms and quality of life change, and it will mainly look at “time to treatment failure”—meaning when someone needs another fibroid treatment.

To be eligible, women must be 18 or older, female, and have been enrolled in COMPARE-UF or ULTRA and had a uterine-sparing fibroid treatment at that time. Exclusions include those who didn’t consent to the original studies or who didn’t have a uterine-sparing treatment. This is an observational study, not a test of a new treatment, and results will come from questionnaires about symptoms and quality of life over up to 12 years. The study is currently enrolling by invitation at sites like UCSF, Henry Ford Health, Mayo Clinic, UNC Chapel Hill, and others, with final completion expected in 2027. Data aren’t shared as individual patient data.

Gender

FEMALE

Eligibility criteria

• 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