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Testing Menstrual Blood Samples to Screen for Cervical Cancer

Studies a self-collected menstrual blood test for HPV to screen women for cervical cancer.

Key facts

Who runs it
Zhongnan Hospital
Where
Wuhan, ChinaSee the site
Trial code
Registry title
Cervical Cancer Screening with NGS-HPV Technology Based on Menstrual Blood
Status
Recruiting
People taking part
10,000 people, planned
Started
1 Sept 2021
Expected to end
31 Mar 2028
Type of study
Observational
Record updated
18 February 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women who plan to have cervical cancer screening and have regular periods. It tests menstrual blood self-sampling to find HPV.

Age
20 Years to 60 Years
Sex
Women only

Main reasons for not taking part

  • No periods (amenorrhea) or menopause
  • Infection of the genital tract
  • Refusing to take part in the study

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • plan to undergo cervical screening
  • with regular menstruation (21-35 days)
  • agree to participate in this study and have signed an informed consent form

Who cannot take part

  • suffering from genital tract infection
  • with amenorrhea or menopause
  • refuse to participate in this study

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 20 and 60 years old?

Where in China

  • Department of Gynecologic OncologyWuhan, ChinaContact: Zheng Hu, doctorTaking people

About the trial

What the trial wants to find out

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 :

Read full original descriptionShow less

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Cervical Cancer Screening with NGS-HPV Technology Based on Menstrual Blood
Plain-language title
Testing Menstrual Blood Samples to Screen for Cervical CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06082765, who can take part
Publications
Record updated
18 February 2025