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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 60
Healthy Volunteers: t
View:

• plan to undergo cervical screening

• with regular menstruation (21-35 days)

• agree to participate in this study and have signed an informed consent form

Locations
Other Locations
China
Department of Gynecologic Oncology
RECRUITING
Wuhan
Contact Information
Primary
Chen Cao, doctor
caochen@zxhospital.com
+8613986276703
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 10000
Sponsors
Collaborators: Dawu County People's Hospital, Zaoyang Maternal and Child Health Hospital, Wuhan Third People's Hospital, Wuhan Central Hospital, Wuxue First People's Hospital, Huanggang Maternal and Child Health Hospital, Zhongxiang Maternal and Child Health Hospital, Gucheng County People's Hospital, Zhongxiang People's Hospital, Yingshan County People's Hospital, Guilin People's Hospital, Jingshan People's Hospital, Yichang Second People's Hospital, The First People's Hospital of Tianmen, Huangmei County People's Hospital, Huangmei Maternal and Child Health Care Hospital
Leads: Zhongnan Hospital

This content was sourced from clinicaltrials.gov