Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia

Trial Title: Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia

NCT ID: NCT05640700

Condition: Human Papilloma Virus
Vaginal Flora Imbalance
Cancer Cervix Uterus
Cervical Dysplasia

Conditions: Official terms:
Papilloma
Uterine Cervical Dysplasia
Precancerous Conditions

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

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.

Criteria for eligibility:

Study pop:
1) Individuals that underwent an HPV PCR cervical screening test and were found to be negative for HPV (healthy controls, n=45) 2) Women that were found to be positive for high risk-HPV but have no cervical dysplasia (n=30) 3) Women who are positive for high risk-HPV and exhibit cervical pathology, either high-CIN (CIN 2-3) or CC (n=15).

Sampling method: Non-Probability Sample
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

Gender: Female

Gender based: Yes

Gender description: people with cervix uterus

Minimum age: 25 Years

Maximum age: 70 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Hadassah Medical Center

Address:
City: Jerusalem
Country: Israel

Status: Recruiting

Contact:
Last name: Ahinoam Lev Sagie, MD

Phone: +972-54-4327178
Email: levsagie@netvision.net.il

Start date: November 9, 2022

Completion date: December 30, 2024

Lead sponsor:
Agency: Hadassah Medical Organization
Agency class: Other

Source: Hadassah Medical Organization

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05640700