Cervical Cancer Screening Strategies

Recruiting

• Conditions: Cancer Screening; Human Papillomavirus Infection; Cervical Cancer; Cervical Cytology; Cervical Intraepithelial Neoplasia

• Registration Number: NCT05309122
• Lead Sponsor: Lei Li

Brief 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+.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-19
• Study First Submitted: 2022-03-25
• Study First Submitted QC: 2022-03-25
• Last Update Submitted: 2022-03-25
• Study First Posted: 2022-04-04
• Last Update Posted: 2022-04-04
• Primary Completion: 2024-03-19
• Study Completion: 2025-03-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CIN2+	One year	CIN2+ detected by various screening methods

Secondary Outcome Measures

Name	Time	Method
Vaginal intraepithelial neoplasia (VaIN)	One year	VaIN detected by various screening methods
Invasive procedures	One year	Invasive procedures needed according to the screening results
Vulval intraepithelial neoplasia (VIN)	One year	VIN detected by various screening methods

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China