Clinical trial · Observational
Cervical Cancer Screening with NGS-HPV Technology Based on Menstrual Blood
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- HPV detection in menstrual blood
- timeFrame
- December 31, 2025
- description
- In phase I: The primary aim of this study is to evaluate the accuracy of menstrual blood (MB) self-sampling for detecting cervical intraepithelial neoplasia grade two or worse (CIN2+) in the general population. In phase II: The primary aim of this study is to evaluate additional molecular markers (specifically DNA methylation) to optimizeThis 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.
Secondary outcomes (1)
- measure
- HPV detection in menstrual blood
- timeFrame
- December 31, 2025
- description
- The secondary objective of this study is to evaluate the accuracy of minipad as a special device for menstrual blood (MB) collection in detecting grade 2 or more cervical intraepithelial neoplasia (CIN2+) in the general population
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTian X, Cao C, Wang L, Zhang J, Chen Y, Tian R, Zhou B, Sun L, Zhang C, Gan L, Jin Y, Liu J, Wang T, Shen Y, Huang S, Zhang L, Zhang S, Chen P, Tong C, Kang J, Fan H, Zhou G, Xiang L, Wen Y, Gan R, Chen Y, Li X, Zhai L, Zhang Q, Ma D, Han Z, Hu Z. Testing menstrual blood for human papillomavirus during cervical cancer screening in China: cross sectional population based study. BMJ. 2026 Feb 4;392:e084831. doi: 10.1136/bmj-2025-084831. PMID 41638692