Cervical cancer screening using menstrual blood and HPV detection technology
Cervical Cancer Screening with NGS-HPV Technology Based on Menstrual Blood
Zhongnan Hospital · NCT06082765
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 |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | Female |
| Sponsor | Zhongnan Hospital (other) |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06082765 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women who plan to undergo cervical screening and have regular menstrual cycles.
Not a fit: Patients who are amenorrheic, menopausal, or suffering from genital tract infections may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Wuhan, Hubei
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cervical Cancer, HPV, menstrual blood, cervical cancer, screening,