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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| University of California, San Francisco | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NA- no intervention | Other | NA- no intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Time to treatment failure | The need for another uterine fibroid treatment procedure | Up to 12 years |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who were previously enrolled in either the COMPARE-UF or ULTRA study
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| Name | Affiliation | Role |
|---|---|---|
| Ganesa Wegienka, PhD | Henry Ford Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States | ||
| Henry Ford Health |
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| Label | URL |
|---|---|
| ALOFT study landing page | View source |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Detroit |
| Michigan |
| 48202 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |