NCT06082765

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Sep 2021Mar 2028

Study Start

First participant enrolled

September 1, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Expected
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

4.3 years

First QC Date

October 7, 2023

Last Update Submit

February 17, 2025

Conditions

Cervical Cancer

Keywords

HPVmenstrual bloodcervical cancerscreening,

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • HPV detection in menstrual blood

    December 31, 2025

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gynecologic Oncology

Wuhan, Hubei, 430062, China

RECRUITING

Related Publications (1)

  • Tian 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: 41638692DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The study aims to collect sanitary napkins for menstrual blood which contains cells.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Zheng Hu, doctor

    Zhongnan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Cao, doctor

CONTACT

+8613986276703caochen@zxhospital.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2023

First Posted

October 13, 2023

Study Start

September 1, 2021

Primary Completion

December 31, 2025

Study Completion (Estimated)

March 31, 2028

Last Updated

February 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available to other researchers.

Locations

CN(1)