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NCT06082765 Clinical Trial

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

Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06082765
Other study ID # 2023071K
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date March 31, 2028

Study information
Verified date August 2023
Source Zhongnan Hospital
Contact Ye Chen, doctor
Phone +8615920177591
Email cy0914@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10000
Est. completion date March 31, 2028
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 55 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Department of Gynecologic Oncology Wuhan Hubei

Sponsors (1)
Lead Sponsor Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary HPV detection in menstrual blood Exploring the concordance between MB-HPV and cobas-HPV December 31, 2023
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