Clinical Evaluation of Detection of High Risk HPV in Urine

• Conditions: High-Grade Squamous Intraepithelial Lesions; Human Papillomavirus Infection; Negative for Intraepithelial Lesion or Malignancy; Atypical Squamous Cells, Cannot Rule Out High-grade Squamous Intraepithelial Lesion; Adenocarcinoma in Situ; Cervical Cancer; Human Papilloma Virus; Atypical Squamous Cells of Undetermined Significance; Cervical Squamous Intraepithelial Lesion; Atypical Glandular Cells

• Registration Number: NCT05210348
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-09-15
• Status Verified: 2021-12
• Study First Submitted: 2022-01-07
• Study First Submitted QC: 2022-01-21
• Last Update Submitted: 2022-01-21
• Study First Posted: 2022-01-27
• Last Update Posted: 2022-01-27
• Primary Completion: 2022-02-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Verification of accuracy	2022/5	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.

Secondary Outcome Measures

Name	Time	Method
Clinical validity verification	2022/5	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)

Trial Locations

Locations (3)

The Third Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China