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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

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