Adenocarcinoma in Situ, Atypical Glandular Cells, Atypical Glandular Cells, Favor Neoplastic, Atypical Glandular Cells Not Otherwise Specified, Atypical Squamous Cells, Cannot Rule Out High-grade Squamous Intraepithelial Lesion, Atypical Squamous Cells of Undetermined Significance, Cervical Adenocarcinoma, Cervical Cancer, Cervical Intraepithelial Neoplasia Grade I, Cervical Intraepithelial Neoplasia Grade II, Cervical Intraepithelial Neoplasia, Grade III, Cervical Squamous Cell Carcinoma, Cervical Squamous Intraepithelial Lesion, High-Grade Squamous Intraepithelial Lesions, Human Papillomavirus Infection, Low-Grade Squamous Intraepithelial Lesions, Negative For Intraepithelial Lesion Or Malignancy
Conditions
Keywords
Self-sampling HPV testing, Human papilloma virus, Cervical cancer
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
Interventions
None listed
Sponsors
BeijingNewBiorayTechnologyCo.,Ltd.
Hangzhou Newhorizon Health Technology Co., Ltd.
Peking University People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
China
Outcome results
None listed