Cervical Cancer Screening with NGS-HPV Technology Based on Menstrual Blood

Recruiting now

Conditions studied: Cervical Cancer

In brief

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.

Key facts

Study ID

NCT06082765

Run by

Zhongnan Hospital

People needed

10000

Starts

2021-09-01

Expected to finish

2028-03-31

Last updated by the study team

2025-02-18

Who can join

Age: 20 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Department of Gynecologic Oncology — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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