Long term effectiveness of uterine sparing fibroid treatments - the lifetime cumulative incidence of uterine leiomyomas (fibroids or UF) is >80% among black women and ~70% in white women

Active Project Grant Awarded Last action

Award ID
R01HD109127
Recipient
Awarding agency
Obligated
$2,274,781

Award facts

Completion date 79% complete
Place of performance
Detroit, MI 48202, USA

Award details come from USAspending.gov.

Description

UF are the most common reason for hysterectomy in the U.S. And can cause heavy menstrual bleeding requiring blood transfusion(S), pelvic pain, urinary and bowel problems, infertility, and substantial impairment of quality of life (QOL). While alternatives to hysterectomy are available including myomectomy (fibroid removal), uterine artery embolization (UAE), endometrial ablation (EA), and radiofrequency ablation (RFA), there are significant knowledge gaps that preclude the development of evidence-based clinical guidelines to select an appropriate UF treatment. Prior studies of UF treatments have several key deficits including limited follow-up time (40% black) population, and include detailed imaging information (UF size, number and location), and self-reported desire for future fertility obtained prior to the index fibroid treatment. Among women who have undergone one of four uterine-sparing procedures (myomectomy, EA, UAE and RFA), validated questionnaires from pre-procedure will be repeated annually up to 10 years post-procedure, to achieve the following: aim 1: compare changes in fibroid symptoms and quality of life from pre-procedure up to 10 years post-procedure among four uterine-sparing procedures: myomectomy, EA, UAE, and RFA. Aim 2: compare the rate of and time until treatment failure up to 10 years after the index treatment among participants who had myomectomy, EA, UAE, and RFA. Aim 3: identify baseline factors that predict clinical effectiveness after myomectomy, EA, UAE, and RFA and with patient and provider input, create a clinical prediction tool (fibroid treatment calculator) that supports informed decision-making. Our preliminary data demonstrate ongoing active engagement of these participants. This project is a time-limited opportunity that uses two well-designed longitudinal cohorts with comprehensive baseline information collected with validated questionnaires and will yield results for immediate application in clinical care.

Transactions

Action Obligated Date
Amendment $597,502
Amendment $600,362
Amendment $592,123
Original award $484,794

Subawards

Subrecipient Amount Awarded
The George Washington University Dr. Nicholson will collaborate with HF to develop strategies for encouraging existing COMPARE-UF participants to take part in the ALOFT follow-up study. $20,255
Subrecipient not on record In this proposal, we will enroll 700 racially and ethnically diverse COMPARE-UF and ULTRA participants who have had a uterine-sparing UF treatment to complete… $71,410
University Of North Carolina At Chapel Hill Dr. Vines will serve as the Site Lead/Co-Investigator. In the early stages of COMPARE-UF, Dr. Vines worked closely with Dr. Nicholson to develop an algorithm… $90,677
Subrecipient not on record Dr. Jacoby will be the Site-Principal Investigator for the proposed study. In the early stages of project work, Dr. Jacoby will collaborate with the Henry… $171,464

Quick answers

Who received award R01HD109127?

R01HD109127 was awarded to Henry Ford Health System by National Institute of Child Health and Human Development (National Institutes of Health) on September 1, 2023.

How much is award R01HD109127 worth?

$2,274,781 has been obligated on R01HD109127.

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