Clinical Evaluation of Detection of High Risk HPV in Urine

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.

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

Sponsors & Collaborators

• Hangzhou Mingze Medical Research Co., Ltd.

  collaborator UNKNOWN

• Beijing Tsingke Biological Technology Co., Ltd. Hangzhou Branch

  collaborator UNKNOWN

• Hangzhou Newhorizon Health Technology Co., Ltd.

  collaborator UNKNOWN

• Peking University People's Hospital

  lead OTHER

Eligibility

Min Age

20 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-09-15

Primary Completion

2022-02-01

Completion

2022-05-01

Countries

• China

Study Locations