UnknownNot Applicable

Clinical Evaluation of Detection of High Risk HPV in Urine

China1,000 participantsStarted 2021-09-15

Plain-language 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.

Who can participate

Age range20 Years – 65 Years

SexFEMALE

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Inclusion criteria

✓. Women aged 20-65 years old;
✓. Have a history of sexual life;
✓. The patients were voluntarily enrolled in the group and signed an informed consent form.

Exclusion criteria

✕. History of cervical conization, pelvic radiation and hysterectomy, acute inflammation of the reproductive tract, severe system disease or other malignant tumors;
✕. Pregnant and lactating women;
✕. The patient's compliance is poor or the researcher thinks it is not suitable for this study.

What they're measuring

Verification of accuracy

Timeframe: 2022/5

Trial details

NCT IDNCT05210348

SponsorPeking University People's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-02-01

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