NCT05613283

Primary Cervical Cancer Screening by Self-sampling HPV Test

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 17,875 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: Female
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Human Papillomavirus Infection
• Cervical Cancer
• Negative For Intraepithelial Lesion Or Malignancy
• Atypical Squamous Cells of Undetermined Significance
• Atypical Squamous Cells, Cannot Rule Out High-grade Squamous Intraepithelial Lesion
• Cervical Squamous Intraepithelial Lesion
• Low-Grade Squamous Intraepithelial Lesions
• High-Grade Squamous Intraepithelial Lesions
• Cervical Intraepithelial Neoplasia Grade I
• Cervical Intraepithelial Neoplasia Grade II
• Cervical Intraepithelial Neoplasia, Grade III
• Atypical Glandular Cells
• Atypical Glandular Cells Not Otherwise Specified
• Atypical Glandular Cells, Favor Neoplastic
• Cervical Squamous Cell Carcinoma
• Adenocarcinoma in Situ
• Cervical Adenocarcinoma

Timeline

• Start date: 2022-11-19
• Primary completion: 2026-07-01
• Completion: 2027-08-31
• First posted: 2022-11-14
• Last updated: 2023-12-21

Locations

6 sites across 1 country: China