## Protocol Section
### Identification Module
**NCT ID:** NCT06430320

**Acronym:** ALOFT

**Brief Title:** Ascertaining Longterm Outcomes of Fibroid Treatments

**Official Title:** Long Term Effectiveness of Uterine Sparing Fibroid Treatments

#### Organization Study ID Info
**ID:** R9NXPE2GTCN9
#### Organization
**Class:** OTHER
**Full Name:** Henry Ford Health System
### Status Module
#### Completion Date
**Date:** 2027-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2025-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Mayo Clinic

**Class:** OTHER

**Name:** University of California, San Francisco

**Class:** OTHER

**Name:** University of North Carolina, Chapel Hill

#### Lead Sponsor

**Class:** OTHER

**Name:** Henry Ford Health System

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Uterine Fibroid

**Keywords:**

- Uterine fibroid treatment

- Multi-center, prospective, observational cohort study

- Uterine-sparing treatment procedures

- Patient-reported outcomes

- Quality of life

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 700

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** NA- no intervention

**Name:** NA- no intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The need for another uterine fibroid treatment procedure

**Measure:** Time to treatment failure

**Time Frame:** Up to 12 years

### Eligibility Module

**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

**Gender Based:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Participants who were previously enrolled in either the COMPARE-UF or ULTRA study

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** San Francisco

**Country:** United States

**Facility:** University of California San Francisco

**State:** California

**Zip:** 94143

**Location 2:**

**City:** Detroit

**Country:** United States

**Facility:** Henry Ford Health

**State:** Michigan

**Zip:** 48202

**Location 3:**

**City:** Rochester

**Country:** United States

**Facility:** Mayo Clinic

**State:** Minnesota

**Zip:** 55905

**Location 4:**

**City:** Chapel Hill

**Country:** United States

**Facility:** The University of North Carolina at Chapel Hill

**State:** North Carolina

**Zip:** 27514

#### Overall Officials

**Official 1:**

**Affiliation:** Henry Ford Health

**Name:** Ganesa Wegienka, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### See Also Links

**Label:** ALOFT study landing page

**URL:** https://www.henryford.com/hcp/research/aloft-study

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009379

- Term: Neoplasms, Muscle Tissue

- ID: D000018204

- Term: Neoplasms, Connective and Soft Tissue

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000009372

- Term: Neoplasms, Connective Tissue

- ID: D000003240

- Term: Connective Tissue Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M10901

- Name: Leiomyoma

- Relevance: HIGH

- As Found: Fibroids

- ID: M25846

- Name: Myofibroma

- Relevance: HIGH

- As Found: Fibroids

- ID: M20350

- Name: Neoplasms, Connective and Soft Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M12317

- Name: Neoplasms, Connective Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007889

- Term: Leiomyoma

- ID: D000047708

- Term: Myofibroma

### Misc Info Module

- Version Holder: 2024-05-31
