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

Vaginal microbiota and chemokine microenvironment in women surgically treated for cervical intraepithelial neoplasia and their association with HPV clearance/persistence

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN34437150

Enrollment

100

Registered

2020-02-21

Start date

2019-01-01

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical intraepithelial neoplasia, HPV, CIN2, CIN3 Cancer cervical intraepithelial neoplasia, HPV

Interventions

The study is only observational, as the surgical intervention to remove the CIN lesion is part of the planned clinical treatment for such type of disease. The study focuses on the cha

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria: 1. Pregnancy 2. Lactation 3. Concomitant infections 4. Concomitant neoplasias

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Presence of pro-inflammatory cytokines in the vaginal microbiome measured by ELISA assays of vaginal secretions collected at baseline and 6 months 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	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026