Examining the vaginal microbiome's role in HPV and cervical dysplasia
Assessing Personalized Vaginal Microbiome Contributions to HPV-driven Pre-malignant and Malignant Cervical Cancer
This study is trying to see if the bacteria in the vagina affect how HPV infection leads to cervical problems like cancer in women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 25 Years to 70 Years |
| Sex | Female |
| Sponsor | Hadassah Medical Organization Academic / other |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT05640700 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect and analyze data on the vaginal microbiome and the presence of HPV in women with cervical pathologies, such as high-grade cervical intraepithelial neoplasia (CIN) and cervical cancer (CC), as well as healthy controls. The researchers will construct a comprehensive dataset to evaluate how the vaginal microbiome may influence the progression from HPV infection to cervical cancer. By understanding the relationship between specific vaginal microorganisms and HPV persistence, the study seeks to identify potential interventions that could reverse HPV persistence and inhibit the progression of cervical lesions.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 25-70 who have attended a clinic for a Pap smear or colposcopy.
Not a fit: Patients who have used antibiotics in the month prior to their clinic visit or any vaginal preparations in the week before sample collection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new strategies for preventing cervical cancer by targeting the vaginal microbiome.
How similar studies have performed: While the role of the vaginal microbiome in HPV persistence is suggested, this study explores a novel approach that has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 25-70 * Attended the clinic for a Pap smear or colposcopy Exclusion Criteria: * Patient does not approve sample collection * Usage of antibiotics in the month prior to clinic visit * Usage of any vaginal preparation or medication in the week prior to sample collection (anti-fungal, spermicides, lubricant etc.) * Menstruation * Pregnancy
Where this trial is running
Jerusalem
- Hadassah Medical Center — Jerusalem, Israel (Recruiting)
Study contacts
- Principal investigator: Ahinoam Lev Sagie, MD — Hadassah Medical Organization
- Study coordinator: Ahinoam Lev Sagie, MD
- Email: levsagie@netvision.net.il
- Phone: +972-54-4327178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.