# Using EV-microRNAs to identify a non-invasive biomarker of uterine fibroid outcomes

> **NIH NIH R21** · GEORGE WASHINGTON UNIVERSITY · 2020 · $239,143

## Abstract

Project Summary
Uterine leiomyomas (fibroids) are a devastating disorder for millions of women, who experience morbidity from
heavy bleeding, pelvic pain, or reproductive problems. They disproportionately impact Black women in the
United States. Progress in identifying risk factors and nonsurgical treatment for fibroids has been slow. One
reason is reliance on ultrasonography for diagnosis and monitoring, which is highly operator dependent, has
poor accuracy in women with multiple fibroids, and provides no molecular information about tumor(s). Our
study will address the critical need to identify sensitive, and specific, mechanistic biomarkers that can help
assess fibroid presence, progression, and potential for future growth through non-invasive means. We will
focus on microRNAs (miRNAs), non-coding RNAs that are highly expressed in fibroid tumor cells and
participate in mechanisms that drive fibroid development by profiling microRNAs packaged in extracellular
vesicles (EV-miRNAs). Circulating EV-miRNAs can be measured non-invasively in plasma and have unique
properties that make them suitable for liquid biopsy applications in research and clinical settings. The long-term
goal of this research is to identify non-invasive biomarkers that can predict fibroid growth and progression. The
objective of the proposed study is to identify EV-miRNAs related to fibroid presence and characterize their
association with clinical measures of disease burden in a racially diverse population. Our central hypothesis is
that a specific pattern of EV miRNAs will be a valid, mechanistic biomarker of fibroid presence and disease
burden. This hypothesis was developed based on strong preliminary data and will be tested through 2 specific
aims. In Aim 1, we propose to establish the relationship between EV-miRNA signatures in plasma and
presence of fibroids using data from 50 women having a hysterectomy for fibroid treatment and 50 controls
having a hysterectomy for pelvic pain or heavy bleeding with no fibroids. In Aim 2, we propose to characterize
the association of plasma EV-miRNA expression and disease burden, measured by fibroid size and menstrual
bleeding severity, among 50 women having a hysterectomy for fibroid treatment (cases from Aim 1) and 100
women with newly detected fibroids, who typically have less severe symptoms and smaller fibroids. The
innovative aspects of our proposal include: the study of EV-miRNAs in fibroids, the multidisciplinary study
team, the overall approach, and the development of liquid biopsy tools. Our proposed study is responsive to
the research priorities of NICHD Gynecologic Health and Disease Branch, which promote the development of
novel biomarkers for fibroids and other gynecologic disorders. This contribution is significant because it will
advance fibroid etiologic research by enabling large, prospective studies of fibroid outcomes with repeated,
mechanistic biomarker measurements. The anticipated outcomes of our proposed study have...

## Key facts

- **NIH application ID:** 9906251
- **Project number:** 5R21HD096248-02
- **Recipient organization:** GEORGE WASHINGTON UNIVERSITY
- **Principal Investigator:** Ami R Zota
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $239,143
- **Award type:** 5
- **Project period:** 2019-04-03 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9906251

## Citation

> US National Institutes of Health, RePORTER application 9906251, Using EV-microRNAs to identify a non-invasive biomarker of uterine fibroid outcomes (5R21HD096248-02). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/9906251. Licensed CC0.

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