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

NCT05946668 | Completed

• 2 other identifiers: OSU-22295NCI-2023-03368
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

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

  The LPR will be calculated by aggregating the Lactobacillus genus counts and dividing by the aggregated Prevotella genus counts. The vaginal dryness (binary, Vaginal Assessment Scale score \<= 2 versus \> 2) will be related to the LPR (continuous) by logistic regression. Will use a two-sided Mann-Whitney-Wilcoxon test with Monte Carlo simulation. Descriptive statistics (frequencies, percentages, means, medians) and correlations will be used to describe sociodemographic factors, clinical factors, and patient reported outcomes. Parametric and nonparametric tests of difference will be used to compare variables.

  Through study completion, an average of 1 year

Study Arms (1)

Observational (vaginal sample, questionnaires, records)

Participants undergo vaginal specimen self-collection via vaginal swab collection kit, complete questionnaires, and have medical records reviewed on study.

Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo vaginal specimen self-collection via vaginal swab collection kit

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Observational (vaginal sample, questionnaires, records)

Electronic Health Record Review OTHER

Medical records reviewed

Observational (vaginal sample, questionnaires, records)

Questionnaire Administration OTHER

Complete questionnaires

Observational (vaginal sample, questionnaires, records)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer receiving endocrine therapy at the Stephanie Spielman Comprehensive Breast Center (SSCBC) at the Ohio State University Medical Center.

You may qualify if:

• Women ages 18 years and older
• Non-metastatic, estrogen and/or progesterone positive, human epidermal growth factor (HER) 2 negative breast cancer who will be receiving endocrine therapy, including tamoxifen, aromatase inhibitor, or ovarian suppression
• Endocrine positive women who have received chemotherapy (adriamycin and cytoxan + taxol; taxotere and cytoxan) will still be eligible but must have completed their treatment

You may not qualify if:

• Triple negative breast cancer patients
• Human epidermal growth factor (HER) 2 positive breast cancer patients
• Metastatic disease

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Elizabeth K Arthur, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 14, 2023
• Study Start: June 6, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)