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NCT05640700
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Conditions: Human Papilloma Virus, Vaginal Flora Imbalance, Cancer Cervix Uterus, Cervical Dysplasia
Sex: Female
Ages: 25 Years – 70 Years
Healthy volunteers: Yes
Enrollment: 99
Sponsor: Hadassah Medical Organization
Location: Hadassah Medical Center Jerusalem
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.
Eligibility Criteria
Inclusion Criteria:
* Age 25-70
* Attended the clinic for a Pap smear or colposcopy
* Findings of high risk-HPV without cervical dysplasia (based on evaluation done in Kupat Holim)
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
Source: ClinicalTrials.gov (NCT05640700). StuddyBuddy aggregates publicly available trial information.
