Clinical trial NCT05210348: Clinical Evaluation of Detection of High Risk HPV in Urine
Official title: Clinical Evaluation Study of Urine hrHPV Detection for the Diagnosis of Presence of Cervical HPV and Correlation of Cervical Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: 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
Keywords: Urine testing for high-risk HPV
Human papilloma virus
Cervical cancer
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Hangzhou Mingze Medical Research Co., Ltd.
name: Beijing Tsingke Biological Technology Co., Ltd. Hangzhou Branch
name: Hangzhou Newhorizon Health Technology Co., Ltd.
First posted: 2022-01-27
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing TCT/HPV/colposcopy in the gynecological clinic or colposcopy clinic of the 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Verification of accuracy
timeFrame: 2022/5
Secondary outcomes:
measure: Clinical validity verification
timeFrame: 2022/5
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Zhengzhou
country: China
facility: The Third Affiliated Hospital of Zhengzhou University
state: Henan
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
References:
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