Primary Cervical Cancer Screening by Self-sampling HPV Test

N/AActive Not RecruitingNCT05613283

Peking University People's Hospital17,875 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

17,875

Conditions

Human Papillomavirus Infection Cervical Cancer Negative For Intraepithelial Lesion Or Malignancy

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (6)

Peking University People's Hospital

Beijing, Beijing Municipality, 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

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

Accuracy verification

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.

Time frame: 2023/12

Clinical validity verification

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.

Time frame: 2027/06