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

October 24, 2023 updated by: Zhongnan Hospital
Our study is conducted to recruit cervical cancer screening patients to evaluate the application value of using high-throughput sequencing technology to detect HPV in menstrual blood for cervical cancer screening.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Our study aims to recruit 10,000 cervical cancer screening patients from the outpatient department of Zhongnan Hospital of Wuhan University from September 1, 2023 to March 31, 2028. The procedures were conducted as below: (1) Conduct cervical cancer screening (TCT+cobas-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 cobas-HPV.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ye Chen, doctor
  • Phone Number: +8615920177591
  • Email: cy0914@163.com

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Our study aims to recruit 10,000 women to explore the application value of HPV detection in menstrual blood using next-generation sequencing.

Description

Inclusion Criteria:

  1. plan to undergo cervical screening
  2. with regular menstruation
  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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV detection in menstrual blood
Time Frame: December 31, 2023
Exploring the concordance between MB-HPV and cobas-HPV
December 31, 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongnan Hospital

Investigators

  • Principal Investigator: Zheng Hu, doctor, Wuhan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

December 31, 2023

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)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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