Cervical Cancer Screening with NGS-HPV Technology Based on Menstrual Blood

Our study is a population-based, cross-sectional study. This study is conducted to recruit cervical cancer screening participants to evaluate the application value of using high-throughput sequencing technology to detect HPV in menstrual blood for cervical cancer screening. Our study is designed as a two-phase study : Phase I : This phase, which will be preparing to recruit 5,000 participants, evaluates the accuracy of menstrual blood (MB) self-sampling for detecting cervical intraepithelial neoplasia grade two or worse (CIN2+) in the general population, with a secondary objective to evaluate the Minipad as a special device to collect MB. Phase II : This phase, which will continue to recruit toward the 10,000-participant target, will evaluate additional molecular markers (specifically DNA methylation) to optimize alternative triage methods for HPV-positive women in menstrual blood (MB) self-sampling. This phase aims to further reduce unnecessary colposcopies while maintaining high sensitivity for CIN2+ detection.

NCT Number	NCT06082765
Lead Sponsor	Zhongnan Hospital Collaborators: Wuhan Central Hospital, Huanggang Maternal and Child Health Hospital, Guilin People's Hospital, Zaoyang Maternal and Child Health Hospital, Jingshan People's Hospital, Yichang Second People's Hospital, Wuhan Third People's Hospital, Dawu County People's Hospital, Yingshan County People's Hospital, Zhongxiang People's Hospital, Zhongxiang Maternal and Child Health Hospital, Wuxue First People's Hospital, The First People's Hospital of Tianmen, Huangmei County People's Hospital, Huangmei Maternal and Child Health Care Hospital, Gucheng County People's Hospital
Conditions	Cervical Cancer
Enrollment	10,000 participants
Start Date	2021-09-01
Primary Completion	2025-12-31 (estimated)
Study Completion	2028-03-31 (estimated)
Updated on ClinicalTrials.gov	2025-02-18