Actively Recruiting
Cervical Cancer Screening with NGS-HPV Technology Based on Menstrual Blood
Led by Zhongnan Hospital · Updated on 2025-02-18
10000
Participants Needed
1
Research Sites
343 weeks
Total Duration
On this page
Sponsors
Z
Zhongnan Hospital
Lead Sponsor
W
Wuhan Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cervical Cancer Screening with NGS-HPV Technology Based on Menstrual Blood
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Plan to undergo cervical screening
- Have regular menstruation with cycles every 21 to 35 days
- Agree to participate in this study and have signed an informed consent form
You will not qualify if you...
- Have amenorrhea or are in menopause
- Currently have a genital tract infection
- Refuse to participate in this study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Gynecologic Oncology
Wuhan, Hubei, China, 430062
Actively Recruiting
Research Team
C
Chen Cao, doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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