Evaluation of Vaginal Microbiome as a Biomarker for the Improvement of Vaginal Health in Women With Breast Cancer, ARISE Study - Trial NCT05946668

Timeline & Enrollment

Primary Outcome

Correlation of Lactobacillus to Prevotella Ratio (LPR) with vaginal dryness

Summary

This study evaluates vaginal microbiome as a biomarker to improve vaginal and sexual health
 in women with breast cancer receiving endocrine therapy. Breast cancer is the most common
 cancer in United States women, aside from skin cancers. Endocrine therapy is standard
 treatment for 70% of invasive breast cancers, significantly affecting sexual health and often
 causing women to change their course of treatment or cease sexual activity. Changes in the
 vaginal microbiome, which is the collection of all microorganisms, such as bacteria, fungi,
 and viruses, that naturally live on and inside the body, are implicated in menopausal-related
 sexual health symptoms, but the vaginal microbiome (and associated immune responses) has not
 been explored as a biomarker for sexual health changes in hormone-related sexual health
 symptoms in breast cancer. A biomarker is a biological molecule found in blood, other body
 fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or
 disease. Ribonucleic acid (RNA)-sequencing is a cost-effective method to analyze both human
 and microbial transcripts. The RNA that is sequenced from a standard biological sample such
 as a swab is a snapshot of the expression of many different cells and can be used to
 simultaneously measure the quantities of microbes, the overall expression of the human host,
 and the quantities of immune cells. Information gathered from this study may help researchers
 establish the vaginal microbiome as a biomarker and therapeutic target to improve the vaginal
 and sexual health of women with breast cancer receiving endocrine therapy.

ICD-10 Classifications