Spots Global Cancer Trial Database for Primary Cervical Cancer Screening by Self-sampling HPV Test
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Trial Identification
Brief Title: Primary Cervical Cancer Screening by Self-sampling HPV Test
Official Title: Primary Cervical Cancer Screening by Self-sampling HPV Test
Study ID: NCT05613283
Conditions
Interventions
Study Description
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
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
Peking University People's Hospital, Beijing, Beijing, 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
Contact Details
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