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Trial Title:
Evaluation of Vaginal Microbiome as a Biomarker for the Improvement of Vaginal Health in Women With Breast Cancer, ARISE Study
NCT ID:
NCT05946668
Condition:
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo vaginal specimen self-collection via vaginal swab collection kit
Arm group label:
Observational (vaginal sample, questionnaires, records)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Medical records reviewed
Arm group label:
Observational (vaginal sample, questionnaires, records)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Complete questionnaires
Arm group label:
Observational (vaginal sample, questionnaires, records)
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.
Detailed description:
PRIMARY OBJECTIVE:
I. 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:
I. 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.
Criteria for eligibility:
Study pop:
Patients with breast cancer receiving endocrine therapy at the Stephanie Spielman
Comprehensive Breast Center (SSCBC) at the Ohio State University Medical Center.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Triple negative breast cancer patients
- Human epidermal growth factor (HER) 2 positive breast cancer patients
- Metastatic disease
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elizabeth K. Arthur, PhD
Phone:
614-293-0811
Email:
Liz.Arthur@osumc.edu
Investigator:
Last name:
Elizabeth K. Arthur, PhD
Email:
Principal Investigator
Start date:
June 6, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05946668
http://cancer.osu.edu
