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Fibroids, UterineCOMPARE-UFNCT02260752

Patient Centered Results for Uterine Fibroids

An observational study of Fibroids, Uterine, run by Duke University at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 54 years, women only
Conditions the study is for
Fibroids, Uterine
What is being tested?
hysterectomy, Uterine arterial embolization and myomectomy
Type of treatment
Surgery or procedure
How many people
3,094 participants
Where
9 sitesUnited States
Study dates
Nov 2015to 30 Apr 2020
How long will I take part?
3 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 54 years
  • Women only
  • No healthy volunteers
  • Adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Uniformed Services University of the Health Sciences

    Bethesda, Maryland, 20814

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Inova Health Systems

    Falls Church, Virginia, 22042

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California Medical Centers

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: Comparing Options for Management: Patient Centered Results for Uterine Fibroids

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.

Read the 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.

Being tested
hysterectomy, Uterine arterial embolization, myomectomy, Medical Therapy, endometrial ablation
Medical subject headings
Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hysterectomyProcedure or surgery

    surgical removal of the uterus

  • Uterine arterial embolizationProcedure or surgery

    Also called UAE

    In uterine artery embolization, doctor uses a slender, flexible tube (catheter) to inject small particles (embolic agents) into the uterine arteries, which supply blood to your fibroids and uterus.the embolic agents are injected into these fibroid blood vessels. The goal is to block the fibroid vessels, starving the fibroids and causing them to shrink and die.

  • myomectomyProcedure or surgery

    surgical procedure to remove uterine fibroids, but does not remove uterus

  • Medical TherapyDrug

    treatment of uterine fibroids with only medications, no procedure or surgery is used

  • endometrial ablationProcedure or surgery

    Also called NovaSure, Her Option, HydroTherm

    surgical procedure that destroys uterine lining via a telescope placed inside the uterus

  • magnetic resonance guided focused ultrasoundProcedure or surgery

    Also called MRgFUS, ExAblate; Sonalleve

    procedure that destroys fibroids while inside an MRI machine

  • radiofrequency ablationProcedure or surgery

    Also called Accessa

    procedure that uses heat to destroy uterine fibroids

Study groups in NCT02260752
Study groupRoleWhat they receive
MedicalPatients who receive medical therapy only for treatment of their uterine fibroids
Receives: Drug: Medical Therapy
ProcedurePatients who have a hysterectomy, myomectomy, uterine arterial embolization, endometrial ablation, radiofrequency ablation, or magnetic resonance guided focused ultrasound to treat their UF.
Receives: Procedure: hysterectomy; Procedure: Uterine arterial embolization; Procedure: myomectomy; Procedure: endometrial ablation; Procedure: magnetic resonance guided focused ultrasound; Procedure: radiofrequency ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in symptom relief (patient interview)

    degree to which bleeding and pain from uterine fibroids is alleviated

    Measured: 12, 24, 36 months

Secondary outcomes (1)

  1. change in preservation reproductive function (patient interview)

    ability of a woman after receiving treatment for uterine fibroids can conceive and deliver a healthy baby

    Measured: 12, 24, 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2014 (estimated)
  2. Study startNov 2015
  3. Primary completion30 Apr 2020
  4. Study completion30 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,094 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02260752
Sponsor's protocol ID
Pro00057883
Other IDs
RFA-HS-14-006
Acronym
COMPARE-UF
Status last verified
Nov 2020
First submitted
29 Sep 2014
Last updated
18 Nov 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • Anchan RM, Spies JB, Zhang S, Wojdyla D, Bortoletto P, Terry K, Disler E, Milne A, Gargiulo A, Petrozza J, Brook O, Srouji S, Morton CC, Greenberg J, Wegienka G, Stewart EA, Nicholson WK, Thomas L, Venable S, Laughlin-Tommaso S, Diamond MP, Maxwell GL, Marsh EE, Myers ER, Vines AI, Wise LA, Wallace K, Jacoby VL. Long-term health-related quality of life and symptom severity following hysterectomy, myomectomy, or uterine artery embolization for the treatment of symptomatic uterine fibroids. Am J Obstet Gynecol. 2023 Sep;229(3):275.e1-275.e17. doi: 10.1016/j.ajog.2023.05.020. Epub 2023 May 26.

    PubMed 37244458

  • Anchan RM, Wojdyla D, Bortoletto P, Terry K, Disler E, Milne A, Gargiulo A, Petrozza J, Brook O, Srouji S, Morton CC, Greenberg J, Wegienka G, Stewart EA, Nicholson WK, Thomas L, Venable S, Laughlin-Tommaso S, Diamond MP, Maxwell GL, Marsh EE, Myers ER, Vines AI, Wise LA, Wallace K, Jacoby VL, Spies JB. A Comparative Analysis of Health-Related Quality of Life 1 Year Following Myomectomy or Uterine Artery Embolization: Findings from the COMPARE-UF Registry. J Womens Health (Larchmt). 2023 Apr;32(4):423-433. doi: 10.1089/jwh.2022.0133. Epub 2023 Jan 13.

    PubMed 36637808

  • 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.

    PubMed 35216832

  • 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.

    PubMed 34101502

  • 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.

    PubMed 33524308

  • 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.

    PubMed 31678093

  • 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.

    PubMed 31306318

  • 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.

    PubMed 29750955

Questions about this trial

What is this clinical trial studying?

An observational study of Fibroids, Uterine, run by Duke University at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in symptom relief (patient interview) (time frame: 12, 24, 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02260752, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.

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