Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02260752 |
| Other study ID # |
Pro00057883 |
| Secondary ID |
RFA-HS-14-006 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 2015 |
| Est. completion date |
April 30, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
Duke University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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. 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.
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.
