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NCT05946668 · ClinicalTrials.gov registry record
Evaluation of Vaginal Microbiome as a Biomarker for the Improvement of Vaginal Health in Women With Breast Cancer, ARISE Study
A clinical trial, sponsored by Ohio State University Comprehensive Cancer Center.
- Completed
- Registry status
- 35
- Enrollment target
NCT05946668: Completed study, sponsored by Ohio State University Comprehensive Cancer Center.
NCT05946668 is a clinical trial that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 35 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05946668 has completed, sponsored by Ohio State University Comprehensive Cancer Center.
- COMPLETED
- Registry status
- 35 participants
- Enrollment target
Study 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.
Primary Outcome
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,
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Questionnaire Administration
- OTHER Electronic Health Record Review
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2023-06-06 |
| Est. Completion | 2025-03-01 |
What the finished NCT05946668 record still lists
NCT05946668 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 35 participants, a relatively small participant target.
The record links to 0 conditions, and to 3 interventions - of which Biospecimen Collection is the first listed.
NCT05946668 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05946668 about?
NCT05946668 is a clinical study titled "Evaluation of Vaginal Microbiome as a Biomarker for the Improvement of Vaginal Health in Women With Breast Cancer, ARISE Study". 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 br...
What is the current status of trial NCT05946668?
This trial is currently completed. The enrollment target is 35 participants. The study started on 2023-06-06. Estimated completion is 2025-03-01.
What interventions are being tested in trial NCT05946668?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Questionnaire Administration (OTHER), Electronic Health Record Review (OTHER).
Who is sponsoring clinical trial NCT05946668?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
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