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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05309122
Other study ID # EVUCC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 19, 2022
Est. completion date March 19, 2025

Study information

Verified date March 2022
Source Peking Union Medical College Hospital
Contact Lei Li, M.D.
Phone 86-139-1198-8831
Email lileigh@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is to investigate retrospectively the results of cervical cytology and high-risk human papillomavirus in the past 20 years recorded in Peking Union Medical College Hospital. The histological findings after cervical cancer screening were reviewed. The diagnostic values of different screening strategies were compared based on the results of cervical histology. The primary endpoint is the diagnosis of grade 2 cervical intraepithelial neoplasia (CIN2) or more severe lesions (CIN2+). The secondary endpoints include following objectives: (1) the invasive procedures needed according to the screening results; (2) the diagnosis of vaginal and/or vulval intraepithelial neoplasia; (3) the persistence and recurrence of human papillomavirus infection; and (4) the cost-effectiveness of screening strategies for CIN2+.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date March 19, 2025
Est. primary completion date March 19, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Aged 18 years or older - With definite cervical histology after cervical cancer screening, ore with at least one screening test after first testing Exclusion Criteria: - Not meeting all of the inclusion criteria

Study Design


Locations

Country Name City State
China Lei Li Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary CIN2+ CIN2+ detected by various screening methods One year
Secondary Invasive procedures Invasive procedures needed according to the screening results One year
Secondary Vaginal intraepithelial neoplasia (VaIN) VaIN detected by various screening methods One year
Secondary Vulval intraepithelial neoplasia (VIN) VIN detected by various screening methods One year
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