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NCT05946668
Evaluation of Vaginal Microbiome as a Biomarker for the Improvement of Vaginal Health in Women With Breast Cancer, ARISE Study
trial testing Biospecimen Collection in Breast Neoplasms in 35 participants. Completed in 1 March 2025.
1 March 2025
Quick facts
| Lead sponsor | Ohio State University Comprehensive Cancer Center |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 35 |
| Start date | 6 June 2023 |
| Primary completion | 1 March 2025 |
| Estimated completion | 1 March 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Biospecimen Collection — full drug profile →
- Electronic Health Record Review
- Questionnaire Administration
Conditions studied
- Breast Neoplasms — all drugs for Breast Neoplasms →
Sponsor
Ohio State University Comprehensive Cancer Center
Who can join
18 and older, female only, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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Currently open trials in the same condition.
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Other Ohio State University Comprehensive Cancer Center trials
Trials by the same sponsor.
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- NCT07503925 — THRIVE Study: Understanding How Oral Nicotine Pouches Affect Public Health · Phase 4 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05946668 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center
- Last refreshed: 18 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05946668.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing