Human Papillomavirus InfectionCervical CancerNegative For Intraepithelial Lesion Or MalignancyAtypical Squamous Cells of Undetermined SignificanceAtypical Squamous Cells, Cannot Rule Out High-grade Squamous Intraepithelial LesionCervical Squamous Intraepithelial LesionLow-Grade Squamous Intraepithelial LesionsHigh-Grade Squamous Intraepithelial LesionsCervical Intraepithelial Neoplasia Grade ICervical Intraepithelial Neoplasia Grade IICervical Intraepithelial Neoplasia, Grade IIIAtypical Glandular CellsAtypical Glandular Cells Not Otherwise SpecifiedAtypical Glandular Cells, Favor NeoplasticCervical Squamous Cell CarcinomaAdenocarcinoma in SituCervical Adenocarcinoma
Study 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.
Eligibility
Sex
FEMALE
Min age
21 Years
Max age
65 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
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.
Trial sites (6)
Facility
City
Region
Status
Peking University People's Hospital
Beijing
Beijing Municipality
Henan Cancer Hospital
Zhengzhou
Henan
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Hunan Provincial Maternal and Child Health Care Hospital
Changsha
Hunan
Chengdu Women's and Children's Central Hospital
Chengdu
Sichuan
Women's Hospital School Of Medicine Zhejiang University
Hangzhou
Zhejiang
More Peking University People's Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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