Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age25-70
SponsorHadassah Medical Organization
About this trial
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
This trial accepts healthy volunteersQualifiers
Age 25-70
Attended the clinic for a Pap smear or colposcopy
Disqualifiers
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
Trial population
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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
90 Participants
are grouped into 2 trial groupsGroup A: Controls
Group B: Women with HPV
Trial outcomes
Primary outcomes
1
Characterization of the microbiome using molecular methods.
Comparison of microbiome profiles between those with HPV compared to controls without HPV.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov