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

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer

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 Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Chen Cao, doctor; Phone Number: +8613986276703; Email: caochen@zxhospital.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430062
      • Recruiting
      • Department of Gynecologic Oncology
      • Contact: Zheng Hu, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Our study is designed as a two-phase study. The phase I aims to recruit 5,000 women to explore the application value of HPV detection in menstrual blood using next-generation sequencing. The phase II aims to recruit 5,000 women to evaluate additional molecular markers (specifically DNA methylation) to optimize alternative triage methods for HPV-positive women in menstrual blood (MB) self-sampling.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV detection in menstrual blood	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.	December 31, 2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HPV detection in menstrual blood	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	December 31, 2025

Collaborators and Investigators

• Sponsor: Zhongnan Hospital
• Collaborators: Wuhan Central Hospital; The First People's Hospital of Tianmen; Wuxue First People's Hospital; Guilin People's Hospital; Yichang Second People's Hospital; Huanggang Maternal and Child Health Hospital; Zaoyang Maternal and Child Health Hospital; Jingshan People's Hospital; Wuhan Third People's Hospital; Dawu County People's Hospital; Yingshan County People's Hospital; Zhongxiang People's Hospital; Zhongxiang Maternal and Child Health Hospital; Huangmei County People's Hospital; Huangmei Maternal and Child Health Care Hospital; Gucheng County People's Hospital
• Investigators: Principal Investigator: Zheng Hu, doctor, Zhongnan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: October 7, 2023
• First Submitted That Met QC Criteria: October 7, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: HPV; cervical cancer; screening,; menstrual blood
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: 2023071K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No