Clinical trial NCT02260752: Patient Centered Results for Uterine Fibroids
Official title: Comparing Options for Management: Patient Centered Results for Uterine Fibroids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibroids, Uterine
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-10-09
Enrollment: 3094
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10,000 patients diagnosed with UF between the ages of 18 and 54. Patients must have had a menstrual period within the last 12 months. Source documentation of UF must include either imaging or a pathology report.

Brief summary: The overall goal of this project is to better enable patients with uterine fibroids (UF) to make informed decisions about treatment options by leveraging the highest possible evidence of healthcare quality. The foundation of this project will be a multi-site, prospective registry of a diverse group of women who have undergone either medical or surgical treatment for UF.

Specifically, the investigators are interested in: comparing management options for symptom relief; comparing management options for preserving reproductive function; and comparing effectiveness among different subpopulations, including consideration of patient needs and preferences of treatment options.

Detailed description: COMPARE UF will enroll approximately 10,000 subjects across 9 clinical enrolling centers in the US. We anticipate recruitment to last approximately 24 months. Sites will consent interested patients and have them complete a patient contact information form to be used to contact the patient for telephone interviews. Following informed consent, the site will collect clinical information and several patient-reported outcomes scales, including the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QOL), the Menopausal Rating Scale, and the EQ-5D, a standardized measure of general health outcomes.

In year 01 of this study, among patients receiving a procedure to treat their UF, 1000 will be asked to provide two blood samples: the first at time of enrollment (before the procedure) and the second at 12 months after the procedure. Samples will be evaluated for ovarian reserve via a blood assay measurement of anti-mullerian hormone.

Additionally, for patients who have a procedure to treat their UF, they will have a routine clinic follow-up visit, sometime between 6 - 12 weeks post procedure. Additional clinical data will be collected at this time.

For patients who are treated medically, there will be no further study-related clinic visits. Follow-up will occur exclusively by telephone.

All consented patients will complete telephone interviews at approximately 12, 24, and 36 months following the initial procedure. It is anticipated that patients enrolled during the first study year will complete a maximum of three years of follow-up. However, if additional funds become available, the investigators plan to extend the follow-up of enrolled patients to five years.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of UF by imaging or pathology report within 2 years of enrollment initiation.
* Menstrual period within 12 months

Exclusion Criteria:

* Post-menopausal
* Men
* 55 years old or older

Primary outcomes:
measure: change in symptom relief (patient interview)
timeFrame: 12, 24, 36 months
Secondary outcomes:
measure: change in preservation reproductive function (patient interview)
timeFrame: 12, 24, 36 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California Medical Centers
state: California
city: Bethesda
country: United States
facility: Uniformed Services University of the Health Sciences
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Falls Church
country: United States
facility: Inova Health Systems
state: Virginia
Study officials:
affiliation: Duke University
name: Evan R Myers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wise LA, Thomas L, Anderson S, Baird DD, Anchan RM, Terry KL, Marsh EE, Wegienka G, Nicholson WK, Wallace K, Bigelow R, Spies J, Maxwell GL, Jacoby V, Myers ER, Stewart EA. Route of myomectomy and fertility: a prospective cohort study. Fertil Steril. 2022 May;117(5):1083-1093. doi: 10.1016/j.fertnstert.2022.01.013. Epub 2022 Feb 23.
citation: Wallace K, Stewart EA, Wise LA, Nicholson WK, Parry JP, Zhang S, Laughlin-Tommaso S, Jacoby V, Anchan RM, Diamond MP, Venable S, Shiflett A, Wegienka GR, Maxwell GL, Wojdyla D, Myers ER, Marsh E. Anxiety, Depression, and Quality of Life After Procedural Intervention for Uterine Fibroids. J Womens Health (Larchmt). 2022 Mar;31(3):415-424. doi: 10.1089/jwh.2020.8915. Epub 2021 Jun 8.
citation: Wegienka G, Stewart EA, Nicholson WK, Zhang S, Li F, Thomas L, Spies JB, Venable S, Laughlin-Tommaso S, Diamond MP, Anchan RM, Maxwell GL, Marsh EE, Myers ER, Vines AI, Wise LA, Wallace K, Jacoby VL. Black Women Are More Likely Than White Women to Schedule a Uterine-Sparing Treatment for Leiomyomas. J Womens Health (Larchmt). 2021 Mar;30(3):355-366. doi: 10.1089/jwh.2020.8634. Epub 2021 Feb 1.
citation: Laughlin-Tommaso SK, Lu D, Thomas L, Diamond MP, Wallace K, Wegienka G, Vines AI, Anchan RM, Wang T, Maxwell GL, Jacoby V, Marsh EE, Spies JB, Nicholson WK, Stewart EA, Myers ER. Short-term quality of life after myomectomy for uterine fibroids from the COMPARE-UF Fibroid Registry. Am J Obstet Gynecol. 2020 Apr;222(4):345.e1-345.e22. doi: 10.1016/j.ajog.2019.09.052. Epub 2019 Oct 31.
citation: Nicholson WK, Wegienka G, Zhang S, Wallace K, Stewart E, Laughlin-Tommaso S, Thomas L, Jacoby VL, Marsh EE, Wise L, Borah BJ, Spies J, Venable S, Anchan RM, Larry Maxwell G, Diamond M, Lytle B, Myers ER. Short-Term Health-Related Quality of Life After Hysterectomy Compared With Myomectomy for Symptomatic Leiomyomas. Obstet Gynecol. 2019 Aug;134(2):261-269. doi: 10.1097/AOG.0000000000003354.
citation: Stewart EA, Lytle BL, Thomas L, Wegienka GR, Jacoby V, Diamond MP, Nicholson WK, Anchan RM, Venable S, Wallace K, Marsh EE, Maxwell GL, Borah BJ, Catherino WH, Myers ER. The Comparing Options for Management: PAtient-centered REsults for Uterine Fibroids (COMPARE-UF) registry: rationale and design. Am J Obstet Gynecol. 2018 Jul;219(1):95.e1-95.e10. doi: 10.1016/j.ajog.2018.05.004. Epub 2018 May 8.