Clinical Evaluation of Detection of High Risk HPV in Urine

Study Overview
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Brief Summary
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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.

Detailed Description
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The urine high-risk HPV detection reagent (PCR-fluorescent probe method) developed by Hangzhou Newhorizon Health Technology Co., Ltd. can qualitatively detect 14 high-risk HPV DNA in human urine samples, including HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, and can detect HPV 16 and 18. This test adopts the comparative clinical research method, by collecting urine samples and cervical swab samples from the same subject for HPV nucleic acid detection. Among them, urine samples were tested for high-risk HPV nucleic acid testing and Sanger sequencing, and cervical swab samples were tested with HPV testing kits for cervical swabs that have been on the market. Combined with the clinical diagnosis results of the cases, the performance of the urine HPV detection technology is compared and evaluated. For patients undergoing TCT testing/HPV testing/colposcopy in the gynecological clinic or colposcopy clinic of the hospital, the subjects will be screened through the admission criteria and signed an informed consent; the examiner is required to collect cervical swab samples and, at the same time, issue urine collection When the tube is given to the subject, the subject must collect urine samples by themselves according to the sampling instructions or under the guidance of medical personnel; the patient samples will be tested by Hangzhou Newhorizon Health Technology Co., Ltd.; the clinical examination report will be collected as the case materials of this study.

Official Title
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Clinical Evaluation Study of Urine hrHPV Detection for the Diagnosis of Presence of Cervical HPV and Correlation of Cervical Lesions

Conditions
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Human Papillomavirus Infection, Cervical Cancer, Human Papilloma Virus, Negative for Intraepithelial Lesion or Malignancy, Atypical Squamous Cells of Undetermined Significance, Cervical Squamous Intraepithelial Lesion, Atypical Squamous Cells, Cannot Rule Out High-grade Squamous Intraepithelial Lesion, Low-grade Squamous Intraepithelial Lesion, High-Grade Squamous Intraepithelial Lesions, Cervical Intraepithelial Neoplasia Grade I, Cervical Intraepithelial Neoplasia Grade II, Cervical Intraepithelial Neoplasia, Grade III, Atypical Glandular Cells, Atypical Glandular Cells Not Otherwise Specified, Atypical Glandular Cells, Favor Neoplastic, Cervical Squamous Cell Carcinoma, Adenocarcinoma in Situ, Cervical Adenocarcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 20-65 years old; Have a history of sexual life; The patients were voluntarily enrolled in the group and signed an informed consent form. Exclusion Criteria: History of cervical conization, pelvic radiation and hysterectomy, acute inflammation of the reproductive tract, severe system disease or other malignant tumors; Pregnant and lactating women; The patient's compliance is poor or the researcher thinks it is not suitable for this study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HPV positive group<br> | |
| HPV negative group<br> | |
| Disease group (clinical diagnosis positive)<br>CIN2 and above disease cases, including HSIL or (CIN2, CIN2-3, CIN3) cervical cancer. | |
| Control group (clinical diagnosis is negative)<br>includes other benign lesions such as inflammation, polyps, and HPV-negative cases without pathological diagnosis and no abnormalities in TCT. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urine testing for high-risk HPV, Human papilloma virus, Cervical cancer