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NCT05640700

Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia

StatusActive, Not Recruiting
PhaseNot specified
Primary completion (estimated)

At risk: Primary completion moved 2 years later.

See at-risk trials from Hadassah Medical Organization

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Record History

All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 30, 2025 to Dec 30, 2027 Show 7 more changesShow less
    • Enrollment closed, study ongoing
    • Final enrollment: 99 participants (planned 90)
    • Study completion pushed from Dec 30, 2025 to Dec 30, 2028
    • Trial arms changed: 2 → 3
    • Eligibility criteria expanded, about 20 words
    • Study description expanded, about 311 words
    • Site details revised
  2. Primary and study completion dates: Dec 30, 2024 to Dec 30, 2025v4
  3. Primary completion date: Dec 30, 2023 to Dec 30, 2024v3
  4. Study description shortened, about 21 wordsv2
  5. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Characterization of the microbiome using molecular methods.
Timeframe: 1 year

Arms and interventions

Controls

Healthy women without HPV in their cervical and vaginal sample

Women with HPV without pathology

Women with HPV, with or without cervical intraepithelial neoplasia or carcinoma

Women with HPV and pathology

Positive for HrHPV with cervical pathology (CIN2-3 or cervical carcinoma)

Sites

1 site in 1 country

  • Hadassah Medical CenterJerusalem, Israel