An observational study in Human Papillomavirus Infection, Cervical Cancer and Negative For Intraepithelial Lesion Or Malignancy, sponsored by Peking University People's Hospital. Active, not recruiting at 6 sites in China. Open to female participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-21.
Sponsored by Peking University People's Hospital · Observational
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.
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:
505 studies on the registry are indexed under Papillomavirus Infections; 128 are open to participants now.
This study's planned enrollment of 17,875 is above the median of 400 across 151 observational studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →Peking University People's Hospital is the lead sponsor of 603 studies on the registry; 241 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The population of clinical validity verification is all screening population, that is, women who need to undergo routine cervical cancer screening and the results of cervical cytology are unknown; Accuracy verification needs to include part of the screening population and part of the outpatient population, that is, women who intend or need to undergo colposcopy or cervical cancer screening for clinical visits.
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Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded:
Participants with poor compliance or researchers who believe that they are not suitable to participate in this study.
Subjects meeting any of the following criteria will be excluded:
Assessment reagent urine sample HPV-PCR test result Assessment reagent vaginal secretion sample HPV-PCR test result Comparative Methods NGS Nucleic Acid Sequencing Results
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
Thin-layer liquid-based cytology (TCT) results panel Colposcopy results Tissue biopsy pathological diagnosis result
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.
Time frame: 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.
Time frame: 2027/06
Started Nov 2022 (actual). Primary completion is estimated for Jul 2026, 44 months after the start.
Of 57 non-industry observational studies under Papillomavirus Infections, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 90. This study's planned 44 months is below that.
Counting every sponsor, half of 69 studies reached it within 46 months; a quarter within 21 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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