Cervical cancer screening using menstrual blood and HPV detection technology
Official title: Cervical Cancer Screening with NGS-HPV Technology Based on Menstrual Blood
Run by Zhongnan Hospital · NCT06082765 · Data updated 2026-11-12
This study is testing whether using menstrual blood to check for HPV can help screen for cervical cancer more effectively and safely for women.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 20 Years to 60 Years |
| Sex | Women only |
| Enrollment | 10000 (estimated) |
| Sponsor | Zhongnan Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | September 1, 2021 |
| Main results expected | December 31, 2025 |
| Study ends | March 31, 2028 |
| Registry record updated | February 18, 2025 |
| Trial ID | NCT06082765 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women who plan to undergo cervical screening and have regular menstrual cycles.
✕Probably not a fit
Patients who are amenorrheic, menopausal, or suffering from genital tract infections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the effectiveness of high-throughput sequencing technology for detecting HPV in menstrual blood as a method for cervical cancer screening. It is designed in two phases: the first phase will recruit 5,000 participants to assess the accuracy of menstrual blood self-sampling for detecting cervical intraepithelial neoplasia grade two or worse (CIN2+). The second phase will expand the recruitment to 10,000 participants and will focus on evaluating additional molecular markers to optimize triage methods for HPV-positive women, thereby reducing unnecessary colposcopies. The study will take place across seven sites in Hubei Province from September 2023 to March 2028.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more accessible method for cervical cancer screening using menstrual blood.
How similar studies have gone: While the use of menstrual blood for HPV detection is a novel approach, similar studies have shown promise in utilizing alternative sampling methods for cervical cancer screening.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. plan to undergo cervical screening 2. with regular menstruation (21-35 days) 3. agree to participate in this study and have signed an informed consent form Exclusion Criteria: 1. with amenorrhea or menopause 2. suffering from genital tract infection 3. refuse to participate in this study
Where it's running
-
Department of Gynecologic Oncology
Wuhan, Hubei, China Recruiting
Study contacts
- Principal investigator: Zheng Hu, doctor — Zhongnan Hospital
- Study coordinator: Chen Cao, doctor
- Email: caochen@zxhospital.com
- Phone: +8613986276703
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.