Brief Title
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
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 Type
Observational
Primary Outcome
Verification of accuracy
Secondary Outcome
Clinical validity verification
Condition
Human Papillomavirus Infection
Study Arms / Comparison Groups
HPV positive group
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
1000
Start Date
September 15, 2021
Completion Date
May 1, 2022
Primary Completion Date
February 1, 2022
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.
Gender
Female
Ages
20 Years - 65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT05210348
Organization ID
Urine-hrHPV 2021
Responsible Party
Principal Investigator
Study Sponsor
Peking University People's Hospital
Collaborators
Hangzhou Mingze Medical Research Co., Ltd.
Study Sponsor
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Verification Date
December 2021