Primary Cervical Cancer Screening by Self-sampling HPV Test

Study Overview
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Brief Summary
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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
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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: The sensitivity for detecting CIN2+ The specificity in non-CIN2+ population The risk of developing CIN2+ in test positive cohort and test negative cohort The accuracy of detecting hrHPV

Official Title
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Primary Cervical Cancer Screening by Self-sampling HPV Test

Conditions
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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

Participation Criteria
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Eligibility Criteria
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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: Known pregnant subjects. Participants who have undergone total hysterectomy. 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. 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: Known pregnant subjects. Participants who have undergone total hysterectomy. 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. Those with known history of cervical cancer. Participants who participated in cervical cancer screening programs or underwent cervical cytology within 12 months. Participants with poor compliance or researchers who believe that they are not suitable to participate in this study.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Accuracy verification group<br>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<br>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<br>Thin-layer liquid-based cytology (TCT) results panel Colposcopy results Tissue biopsy pathological diagnosis result | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 2027/06 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-sampling HPV testing, Human papilloma virus, Cervical cancer