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Trial Title:
Cervical Cancer Screening With NGS-HPV Technology Based on Menstrual Blood
NCT ID:
NCT06082765
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
HPV
menstrual blood
cervical cancer
screening,
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
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.
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.
Criteria for eligibility:
Study pop:
Our study aims to recruit 10,000 women to explore the application value of HPV detection
in menstrual blood using next-generation sequencing.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
20 Years
Maximum age:
55 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Department of Gynecologic Oncology
Address:
City:
Wuhan
Zip:
430062
Country:
China
Status:
Recruiting
Contact:
Last name:
Zheng Hu, doctor
Start date:
September 1, 2021
Completion date:
March 31, 2028
Lead sponsor:
Agency:
Zhongnan Hospital
Agency class:
Other
Source:
Zhongnan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06082765