Actively Recruiting

Age: 20Years - 60Years
FEMALE
Healthy Volunteers
NCT06082765

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

Age: 20Years - 60Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Department of Gynecologic Oncology

Wuhan, Hubei, China, 430062

Actively Recruiting

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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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