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

Recruiting

• Conditions: Cervical Cancer

• Registration Number: NCT06082765
• Lead Sponsor: Zhongnan Hospital

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.

Detailed Description

Our study will recruit 10,000 participants for cervical cancer screening across seven sites in Hubei Province from September 1, 2023, to March 31, 2028. The participating sites include: Fruit Lake Community (where Zhongnan Hospital of Wuhan University is located), Jiang'an District (Wuhan Central Hospital), Huangzhou district of Huanggang County (Huanggang Maternal and Child Health Care Hospital), Jingling Community of Tianmen County (the First People's Hospital of Tianmen), Liutang Community of Huangmei County (Huangmei County People's Hospital), Gongtang Community of Zhongxiang City (Zhongxiang Maternal and Child Health Care Hospital), and Chaihu Community of Zhongxiang City (People's Hospital of Zhongxiang).. The procedures were conducted as below: (1) Conduct cervical cancer screening (TCT+hr-HPV) for all the participants. (2) Collect sanitary napkins from participants during their first menstrual period after cervical HPV testing. (3) Detect HPV using high-throughput sequencing technology in the menstrual blood (MB) from sanitary napkins. (4) Colposcopy referral (biopsy if necessary) for patients with abnormal screening results. (5) Compare the concordance between MB-HPV and clinician-collected HPV. (6) Evaluate 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. (7) Evaluate additional molecular markers (specifically DNA methylation) to optimize alternative triage methods for HPV-positive women in menstrual blood (MB) self-sampling.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2023-10-07
• Study First Submitted QC: 2023-10-07
• Study First Posted: 2023-10-13
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-18
• Primary Completion: 2025-12-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HPV detection in menstrual blood	December 31, 2025	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 Outcome Measures

Name	Time	Method
HPV detection in menstrual blood	December 31, 2025	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

Trial Locations

Locations (1)

Department of Gynecologic Oncology; 🇨🇳 Wuhan, Hubei, China