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Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia

Assessing Personalized Vaginal Microbiome Contributions to HPV-driven Pre-malignant and Malignant Cervical Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05640700
Enrollment
90
Registered
2022-12-07
Start date
2022-11-09
Completion date
2025-12-30
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Cervix Uterus, Cervical Dysplasia, Human Papilloma Virus, Vaginal Flora Imbalance

Brief summary

In this study, the investigators will prospectively collect, analyze and integrate information regarding vaginal microbiome composition and HPV presence in women with cervical pathologies (high-grade CIN and CC) and controls, to construct a large dataset from patients with pre-cancerous cervical lesions and healthy women, to evaluate the personalized contribution of the vaginal microbiome to the CIN-CC sequence.

Detailed description

Infection with high-risk Human Papillomavirus (HPV) genotypes constitutes a well-recognized risk factor for cervical-carcinoma (CC). High-risk HPV features 10-15% persistence rate, consequently driving precancerous cervical-intraepithelial-neoplasia (CIN) and subsequent progression to CC. Multiple factors are believed to play permissive roles in the progression of CIN/CC , yet a molecular mechanism driving carcinogenesis across the CIN-CC continuum following persistent HPV infection remains elusive. The vaginal microbiome may play a role in the development of CIN-CC carcinogenesis, by modulation of host-immune-response and alteration of cervical microenvironment to become tumor-permissive. While suggested vaginal microbiome contributions include induction of altered epithelial cell adhesion and downregulation of DNA damage responses, no clear mechanism has been proven to date. The loss of Lactobacillus genus dominancy, and the switch to dysbiotic, high-diversity, high-pH, Bacterial Vaginosis (BV) is thought to play a key-role in HPV infection, persistence and carcinogenesis. the investigators hypothesize that specific vaginal microorganisms may promote HPV persistence, chronic inflammation and progression through the CIN-CC sequence, and the elimination of harmful bacteria or supplementation of beneficial microbes, could possibly reverse HPV persistency and inhibit CIN-CC progression. The current study consists of recruitment of a human cohort of healthy, CIN and CC patients including vaginal samples and comprehensive metadata collection. The investigators plan to conduct an in-depth characterization of vaginal microbiome to identify associations with HPV, CIN and CC.

Interventions

None listed

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Characterization of the microbiome using molecular methods.1 yearComparison of microbiome profiles between those with HPV compared to controls without HPV.

Countries

Israel

Contacts

Primary ContactAhinoam Lev Sagie, MD
levsagie@netvision.net.il+972-54-4327178
Backup ContactLilah Tsaitlin Mor, MD
lilah.tsaitlin@gmail.com+972-54-7753434

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026