Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia

Human Papilloma Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05640700
• Other study ID #: HMO-812-21
• Status: Recruiting
• Start date: November 9, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Hadassah Medical Organization
• Contact: Ahinoam Lev Sagie, MD
• Phone: +972-54-4327178
• Email: levsagie[@]netvision.net.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer Cervix Uterus
• Cervical Dysplasia
• Human Papilloma Virus
• Papilloma
• Precancerous Conditions
• Uterine Cervical Dysplasia
• Vaginal Flora Imbalance

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of the microbiome using molecular methods.	Comparison of microbiome profiles between those with HPV compared to controls without HPV.	1 year