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Primary Cervical Cancer Screening by Self-sampling HPV Test — PREVENT  

Cervical Cancer Clinical Trial

Official title:
Primary Cervical Cancer Screening by Self-sampling HPV Test

Clinical Trial Summary

Cervical cancer seriously threatens women's health and HPV infection is the main cause of cervical cancer. Traditionally, Cervical cancer screening is based on cervical exfoliated cell samples collected by health care provider, which is labor consuming and the coverage and compliance are both relatively low in some areas. Non-invasive hrHPV self-sampling test appears to be more acceptable and may improve the HPV screening coverage. This study aims to evaluate the clinical performance of a newly developed urine/vaginal self-sampling hrHPV test in Cervical cancer screening.

Clinical Trial Description

This study is a prospective multi-center clinical trial in China. Eligible participants are cervical cancer screening population who meet the enrollment criterias. All the participants are required to provide urine and vaginal samples by self-sampling, as well as the cervical exfoliated cell samples (by HCP). Participants may undergo colposcopy examination depending on the test results, and they will be followed up for three years. The high-risk human papillomavirus nucleic acid detection kit (PCR-fluorescent probe method) developed by New Horizon Co., Ltd . is suitable for in vitro qualitative detection of 14 types of high-risk HPV ( 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) nucleic acid. The clinical performance of the self-sampling test will be assessed base on the following outcomes: 1. The sensitivity for detecting CIN2+ 2. The specificity in non-CIN2+ population 3. The risk of developing CIN2+ in test positive cohort and test negative cohort 4. The accuracy of detecting hrHPV ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05613283
Study type Observational
Source Peking University People's Hospital
Contact
Status Active, not recruiting
Phase
Start date November 19, 2022
Completion date August 31, 2027
View Details
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