Status:

UNKNOWN

Clinical Evaluation of Detection of High Risk HPV in Urine

Lead Sponsor:

Peking University People's Hospital

Collaborating Sponsors:

Hangzhou Mingze Medical Research Co., Ltd.

Beijing Tsingke Biological Technology Co., Ltd. Hangzhou Branch

Conditions:

Human Papillomavirus Infection

Cervical Cancer

Eligibility:

FEMALE

20-65 years

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....

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 sampl...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 15 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 1 2022

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT05210348

Start Date

September 15 2021

End Date

May 1 2022

Last Update

January 27 2022

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Peking University People's Hospital

Beijing, Beijing Municipality, China

2

The Third Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

3

Nanjing First Hospital

Nanjing, Jiangsu, China