Cervical Intraepithelial Neoplasia Grade 2/3 Clinical Trial
Official title:
Accurate Screening and Prevention of Cervical Lesions-- Development of Accurate Screening Methods for Cervical Lesions
The goal of this observational study is to compare the accuracy and sensitivity of High-throughput human papilloma virus(HPV) typing and integrated assays with routine screening protocols (Cobas HPV test combined with thinprep cytologic test(TCT) for the detection of cervical intraepithelial neoplasia in the general and hospital populations. The main questions it aims to answer are: - High-throughput HPV typing and integrated assays can screen for ≥ cervical intraepithelial neoplasia (CIN2 or CIN3) with high sensitivity and accuracy. - High-throughput HPV typing and integrated assays can be promoted as a screening tool for cervical cancer. Participants will be screened with routine screening protocols (Cobas HPV test combined with TCT test), and if the results are abnormal, colposcopy and cervical biopsy will be performed.
Status | Recruiting |
Enrollment | 15000 |
Est. completion date | November 30, 2024 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. First screening. 2. History of sexual intercourse. Exclusion Criteria: 1. Previous CIN, cervical cancer or other cervical lesions; 2. History of cervical treatment; 3. Age <25, >70 years; 4. Pregnancy. |
Country | Name | City | State |
---|---|---|---|
China | Women's hospital school of medicine zhejiang university | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Women's Hospital School Of Medicine Zhejiang University | Tongji Hospital, Wuhan Central Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the risk of cervical intraepithelial neoplasia(CIN) 2 or worse | Patients who meet the requirements for referral colposcopy were further examined for CIN2+ by pathology. | 3 years |
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