Breast NeoplasmsNCT05946668
Evaluation of Vaginal Microbiome as a Biomarker for the Improvement of Vaginal Health in Women With Breast Cancer, ARISE Study
An observational study of Breast Neoplasms, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Biospecimen Collection, Electronic Health Record Review and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2023to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer receiving endocrine therapy at the Stephanie Spielman Comprehensive Breast Center (SSCBC) at the Ohio State University Medical Center.
Who may be able to join
- 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
Who cannot join
- Triple negative breast cancer patients
- Human epidermal growth factor (HER) 2 positive breast cancer patients
- Metastatic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: The VAginal Microbiome as a BiomaRker of VagInal Health in Women With BreaSt CancEr (ARISE)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Determine whether individuals who experience vaginal dryness have a distinct microbiome prior to treatment from those who do not in a sample of breast cancer survivors initiating endocrine therapy.
EXPLORATORY OBJECTIVE:
- Explore potential mechanisms of microbiome-associated vaginal toxicity through correlation with host gene expression and deconvolved immune cell abundances.
OUTLINE: This is an observational study.
Participants undergo vaginal specimen self-collection via vaginal swab collection kit, complete questionnaires, and have medical records reviewed on study.
- Conditions
- Breast Neoplasms
- Being tested
- Biospecimen Collection, Electronic Health Record Review, Questionnaire Administration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo vaginal specimen self-collection via vaginal swab collection kit
Electronic Health Record ReviewOther
Medical records reviewed
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start6 Jun 2023
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Arthur, Ohio State University Comprehensive Cancer Center
- Investigators
- Elizabeth K Arthur, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946668
- Sponsor's protocol ID
- OSU-22295
- Other IDs
- NCI-2023-03368
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2023
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VAginal Microbiome as a BiomaRker of VagInal Health in Women With BreaSt CancEr (ARISE)
- ClinicalTrials.gov ID
- NCT05946668
- Acronym / sponsor ID
- OSU-22295
- Conditions
- Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- Determine whether individuals who experience vaginal dryness have a distinct microbiome prior to treatment from those who do not in a sample of breast cancer survivors initiating endocrine therapy.
EXPLORATORY OBJECTIVE:
- Explore potential mechanisms of microbiome-associated vaginal toxicity through correlation with host gene expression and deconvolved immune cell abundances.
OUTLINE: This is an observational study.
Participants undergo vaginal specimen self-collection via vaginal swab collection kit, complete questionnaires, and have medical records reviewed on study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (vaginal sample, questionnaires, records) | – | Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Other: Questionnaire AdministrationParticipants undergo vaginal specimen self-collection via vaginal swab collection kit, complete questionnaires, and have medical records reviewed on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer receiving endocrine therapy at the Stephanie Spielman Comprehensive Breast Center (SSCBC) at the Ohio State University Medical Center.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Triple negative breast cancer patients
- Human epidermal growth factor (HER) 2 positive breast cancer patients
- Metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo vaginal specimen self-collection via vaginal swab collection kit | Procedure or surgery | Observational (vaginal sample, questionnaires, records) |
| Electronic Health Record ReviewMedical records reviewed | Other | Observational (vaginal sample, questionnaires, records) |
| Questionnaire AdministrationComplete questionnaires | Other | Observational (vaginal sample, questionnaires, records) |
Primary outcome
Correlation of Lactobacillus to Prevotella Ratio (LPR) with vaginal dryness
Time frame: Through study completion, an average of 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth K Arthur, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Lactobacillus to Prevotella Ratio (LPR) with vaginal dryness (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.