Clinical Evaluation of Detection of High Risk HPV in Urine (Urine-hrHPV)

Peking University

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT05210348

Urine-hrHPV 2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,000 participants in 4 patient groups

HPV positive group

HPV negative group

Disease group (clinical diagnosis positive)

Description:

CIN2 and above disease cases, including HSIL or (CIN2, CIN2-3, CIN3) cervical cancer.

Control group (clinical diagnosis is negative)

Description:

includes other benign lesions such as inflammation, polyps, and HPV-negative cases without pathological diagnosis and no abnormalities in TCT.