Primary Cervical Cancer Screening by Self-sampling HPV Test

Active, not recruiting

• Conditions: Low-Grade Squamous Intraepithelial Lesions; Adenocarcinoma in Situ; Human Papillomavirus Infection; Negative For Intraepithelial Lesion Or Malignancy; Cervical Intraepithelial Neoplasia, Grade III; Atypical Glandular Cells; Atypical Glandular Cells Not Otherwise Specified; Cervical Adenocarcinoma; Cervical Cancer; Atypical Squamous Cells, Cannot Rule Out High-grade Squamous Intraepithelial Lesion

• Registration Number: NCT05613283
• Lead Sponsor: Peking University People's Hospital

Brief 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

Study Timeline

• Study First Submitted: 2022-11-04
• Study First Submitted QC: 2022-11-04
• Study First Posted: 2022-11-14
• Study Start: 2022-11-19
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-21
• Primary Completion: 2026-07
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 17875

Inclusion Criteria

• a. Females aged 21-65; b. have a history of sexual life; c. The patients were voluntarily enrolled and signed the informed consent.

Exclusion Criteria

• Accuracy Verification:

Subjects meeting any of the following criteria will be excluded:

1. Known pregnant subjects.

2. Participants who have undergone total hysterectomy.

3. Participants who have received cervical resection therapy or ablative therapy within 12 months, such as cryo, laser, microwave, coagulation, cryotherapy, LEEP, large loop electrosurgery (LLETZ), cold knife conization (CKC), laser conization, or ablation.

4. Participants with poor compliance or researchers who believe that they are not suitable to participate in this study.

   • Primary screening use:

Subjects meeting any of the following criteria will be excluded:

1. Known pregnant subjects.
2. Participants who have undergone total hysterectomy.
3. Participants who have received cervical resection therapy or ablative therapy within 12 months, such as cryo, laser, microwave, coagulation, cryotherapy, LEEP, large loop electrosurgery (LLETZ), cold knife conization (CKC), laser conization, or ablation.
4. Those with known history of cervical cancer.
5. Participants who participated in cervical cancer screening programs or underwent cervical cytology within 12 months.
6. Participants with poor compliance or researchers who believe that they are not suitable to participate in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical validity verification	2027/06	The consistency of HPV detection of different sample types was analyzed, and the absolute risk value, relative risk value and 95% confidence interval of the development of ≥CIN2 in different primary screening types were calculated and used to verify the safety and effectiveness of the intended use of cervical cancer primary screening.
Accuracy verification	2023/12	Calculate the positive coincidence rate, negative coincidence rate, total coincidence rate, and Kappa value of the comparison reagents and calculate the 95% confidence interval to verify the accuracy of detecting HPV infection.

Trial Locations

Locations (6)

Chengdu Women's and Children's Central Hospital; 🇨🇳 Chengdu, Sichuan, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

The Third Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Hunan Provincial Maternal and Child Health Care Hospital; 🇨🇳 Changsha, Hunan, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Women's Hospital School Of Medicine Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China