Cervical Cancer Clinical Trial
— Urine-hrHPVOfficial title:
Clinical Evaluation Study of Urine hrHPV Detection for the Diagnosis of Presence of Cervical HPV and Correlation of Cervical Lesions
Verified date | December 2021 |
Source | Peking University People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Cervical cancer is one of the most common tumors in women, which seriously threatens women's life quality and safety. Human papilloma virus (HPV) infection is the most common cause of cervical cancer. Traditional HPV testing is based on the cells sample shed from the cervix. Recent studies have shown that urine HPV detection can be used as a new HPV detection method. This study intends to include patients undergoing TCT /HPV test/colposcopy in the department of gynecological diseases of the hospital, and collect urine samples and cervical swab samples. Sanger sequencing and cervical swab HPV test results were compared to evaluate the accuracy and clinical validity of urine HPV test combined with clinical diagnosis results of cases.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | May 1, 2022 |
Est. primary completion date | February 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Women aged 20-65 years old; 2. Have a history of sexual life; 3. The patients were voluntarily enrolled in the group and signed an informed consent form. Exclusion Criteria: 1. History of cervical conization, pelvic radiation and hysterectomy, acute inflammation of the reproductive tract, severe system disease or other malignant tumors; 2. Pregnant and lactating women; 3. The patient's compliance is poor or the researcher thinks it is not suitable for this study. |
Country | Name | City | State |
---|---|---|---|
China | Peking University People's Hospital | Beijing | Beijing |
China | Nanjing First Hospital | Nanjing | Jiangsu |
China | The Third Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Peking University People's Hospital | Beijing Tsingke Biological Technology Co., Ltd. Hangzhou Branch, Hangzhou Mingze Medical Research Co., Ltd., Hangzhou Newhorizon Health Technology Co., Ltd. |
China,
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Verification of accuracy | Consistency analysis of urine HPV test and Sanger sequencing results/cervical swab HPV test results The main evaluation indicators are the total test positive coincidence rate, total test negative coincidence rate, total coincidence rate, 16/18/other 12 types of positive and negative coincidence rates, kappa value and 95% confidence interval. | 2022/5 | |
Secondary | Clinical validity verification | Using the clinical diagnosis result (colposcopy or pathology report) of the case as the gold standard, evaluate the sensitivity, specificity and the corresponding 95% confidence interval, etc. of the HPV detection of urine samples and cervical swab samples for cervical intraepithelial neoplasia grade II and above (=CIN2) | 2022/5 |
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