Primary Cervical Cancer Screening by Self-sampling HPV Test

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Human Papillomavirus Infection Adenocarcinoma Adenocarcinoma in Situ Atypical Glandular Cells Atypical Glandular Cells Not Otherwise Specified Atypical Glandular Cells, Favor Neoplastic Atypical Squamous Cells of Undetermined Significance Atypical Squamous Cells of the Cervix Atypical Squamous Cells, Cannot Rule Out High-grade Squamous Intraepithelial Lesion Carcinoma Carcinoma in Situ 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 Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female High-Grade Squamous Intraepithelial Lesions Infections Low-Grade Squamous Intraepithelial Lesions Morphological and Microscopic Findings Negative For Intraepithelial Lesion Or Malignancy Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Squamous Intraepithelial Lesions Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

21 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Peking University People's Hospital, Beijing, Beijing Municipality, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Accuracy verification

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

BeijingNewBiorayTechnologyCo.,Ltd.
Hangzhou Newhorizon Health Technology Co., Ltd.

Registry information

Acronym: PREVENT

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2027
First posted: Nov 14, 2022
Registry last updated: Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting