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

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.

Conditions

• Cervical Cancer

Sponsors & Collaborators

• Wuhan Central Hospital

  collaborator OTHER

• Huanggang Maternal and Child Health Hospital

  collaborator UNKNOWN

• Guilin People's Hospital

  collaborator UNKNOWN

• Zaoyang Maternal and Child Health Hospital

  collaborator UNKNOWN

• Jingshan People's Hospital

  collaborator UNKNOWN

• Yichang Second People's Hospital

  collaborator OTHER

• Wuhan Third People's Hospital

  collaborator UNKNOWN

• Dawu County People's Hospital

  collaborator UNKNOWN

• Yingshan County People's Hospital

  collaborator UNKNOWN

• Zhongxiang People's Hospital

  collaborator UNKNOWN

• Zhongxiang Maternal and Child Health Hospital

  collaborator UNKNOWN

• Wuxue First People's Hospital

  collaborator UNKNOWN

• The First People's Hospital of Tianmen

  collaborator UNKNOWN

• Huangmei County People's Hospital

  collaborator UNKNOWN

• Huangmei Maternal and Child Health Care Hospital

  collaborator UNKNOWN

• Gucheng County People's Hospital

  collaborator UNKNOWN

• Zhongnan Hospital

  lead OTHER

Principal Investigators

• Zheng Hu, doctor · Zhongnan Hospital

Eligibility

Min Age

20 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-09-01

Primary Completion

2025-12-31

Completion

2028-03-31

Countries

• China

Study Locations