Clinical trial Recruiting at 1 site Observational Ages 20 to 60 Women only

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 typeObservational
Ages20 Years to 60 Years
SexWomen only
Enrollment10000 (estimated)
SponsorZhongnan Hospital
Academic / other
Locations1 site (Wuhan, Hubei)
StatusRecruiting
StartedSeptember 1, 2021
Main results expectedDecember 31, 2025
Study endsMarch 31, 2028
Registry record updatedFebruary 18, 2025
Trial IDNCT06082765 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.