Impact of vaginal microbiome on HPV clearance and persistence in CIN2-CIN3 wome

Not Applicable

Completed

• Conditions: cervical intraepithelial neoplasia, HPV, CIN2, CIN3; Cancer; cervical intraepithelial neoplasia, HPV

• Registration Number: ISRCTN34437150
• Lead Sponsor: niversity of Ferrara

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/33251154/ (added 01/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-21
• Study Completion: 2020-02-29
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 85

Inclusion Criteria

1. High risk HPV-positive patients
2. CIN2 or CIN3 cervical lesions
3. Planned removal of cervical lesions by surgical intervention

Exclusion Criteria

1. Pregnancy
2. Lactation
3. Concomitant infections
4. Concomitant neoplasias

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The role of the vaginal microbiome in HPV clearance and persistence in CIN patients measured by quantitative real-time PCR microarray of DNA extracted from cervicovaginal swabs taken at baseline and 6 months

Secondary Outcome Measures

Name	Time	Method
<br> 1. Presence of pro-inflammatory cytokines in the vaginal microbiome measured by ELISA assays of vaginal secretions collected at baseline and 6 months<br> 2. Concentration of pro-inflammatory cytokines in the vaginal microbiome measured by analysis of ELISA assays of vaginal secretions collected at baseline and 6 months<br>