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Clinical Trials in Israel / NCT05640700
Recruiting Observational

Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia

NCT05640700 · tracked via the Priya Life Science Israel tracker
Sponsor
Hadassah Medical Organization
Phase
Observational
Started
2022-11-09
Last updated
2025-03-19

Condition(s) studied

Human Papilloma VirusVaginal Flora ImbalanceCancer Cervix UterusCervical Dysplasia

Study 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

Sex
FEMALE
Min age
25 Years
Max age
70 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Characterization of the microbiome using molecular methods. — 1 year
    Comparison of microbiome profiles between those with HPV compared to controls without HPV.

Trial sites (1)

FacilityCityRegionStatus
Hadassah Medical Center Jerusalem Israel Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05640700 on ClinicalTrials.gov ↗ ← All trials in Israel