Clinical Evaluation of Detection of High Risk HPV in Urine

Last updated: January 21, 2022
Sponsor: Peking University People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Adenocarcinoma

Squamous Cell Carcinoma

Genitourinary Cancer

Treatment

N/A

Clinical Study ID

NCT05210348
Urine-hrHPV 2021
  • Ages 20-65
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 consentform.

Exclusion

Exclusion Criteria:

  1. History of cervical conization, pelvic radiation and hysterectomy, acute inflammationof 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 thisstudy.

Study Design

Total Participants: 1000
Study Start date:
September 15, 2021
Estimated Completion Date:
May 01, 2022

Study 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.

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing
    China

    Active - Recruiting

  • The Third Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Active - Recruiting

  • Nanjing First Hospital

    Nanjing, Jiangsu
    China

    Active - Recruiting

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