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

What this Trial Is About

Researchers are studying the vaginal microbiome and its relationship to Human Papillomavirus (HPV) infection and cervical diseases, including pre-cancerous cervical intraepithelial neoplasia (CIN) and cervical cancer (CC). The study aims to understand how the vaginal microbiome may influence HPV persistence and progression from CIN to cervical cancer, by collecting and analyzing samples and clinical data from women with cervical pathologies and healthy controls. Participants include healthy women without HPV and women with HPV infection, some of whom have cervical intraepithelial neoplasia or carcinoma. The study collects vaginal samples and relevant clinical information to characterize the vaginal microbiome using molecular methods over a period of one year. This observational study involves no drug treatments but focuses on detailed biological and clinical data collection. Women enrolled in the study will provide vaginal samples during clinic visits for Pap smear or colposcopy. Researchers will analyze these samples to assess microbiome composition and HPV presence. The primary outcome is the molecular characterization of the microbiome over one year. Participants must meet eligibility criteria and will be monitored for sample collection and clinical assessments during their participation.

Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia