Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT05613283

Primary Cervical Cancer Screening by Self-sampling HPV Test

Conditions: 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

Sex: Female
Ages: 21 Years – 65 Years
Healthy volunteers: 1
Enrollment: 17875
Sponsor: Peking University People's Hospital

Location: China

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 Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05613283). StuddyBuddy aggregates publicly available trial information.