NCT06082765 Cervical Cancer Screening with NGS-HPV Technology Based on Menstrual Blood
| NCT ID | NCT06082765 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhongnan Hospital |
| Condition | Cervical Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2021-09-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Zheng Hu, doctor
PRINCIPAL INVESTIGATOR
Zhongnan Hospital
Frequently Asked Questions
Who can join the NCT06082765 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 60 Years, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06082765 currently recruiting?
Yes, NCT06082765 is actively recruiting participants. Contact the research team at caochen@zxhospital.com for enrollment information.
Where is the NCT06082765 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06082765 clinical trial?
NCT06082765 is sponsored by Zhongnan Hospital. The principal investigator is Zheng Hu, doctor at Zhongnan Hospital. The trial plans to enroll 10,000 participants.
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