Primary Cervical Cancer Screening by Self-sampling HPV Test (PREVENT)

Peking University

Status: Active, not recruiting

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

Study type: Observational

Funder types: Other

Identifiers

NCT05613283

NH-3004

Details and patient eligibility

About

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.

Full 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

Enrollment: 17,875 estimated patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

17,875 participants in 3 patient groups

Accuracy verification group

Description:

Assessment reagent urine sample HPV-PCR test result Assessment reagent vaginal secretion sample HPV-PCR test result Comparative Methods NGS Nucleic Acid Sequencing Results

Consistency verification group

Description:

Assessment reagent urine sample HPV-PCR test result Assessment reagent vaginal secretion sample HPV-PCR test result ApprovedListed Reagent Cervical Sample HPV-PCR Test Result

Efficacy and safety verification group

Description:

Thin-layer liquid-based cytology (TCT) results panel Colposcopy results Tissue biopsy pathological diagnosis result