Primary Cervical Cancer Screening by Self-sampling HPV Test

NCT05613283 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 17875

Last updated 2023-12-21

No results posted yet for this study

Summary

Cervical cancer seriously threatens women's health and HPV infection is the main cause of cervical cancer. Traditionally, Cervical cancer screening is based on cervical exfoliated cell samples collected by health care provider, which is labor consuming and the coverage and compliance are both relatively low in some areas. Non-invasive hrHPV self-sampling test appears to be more acceptable and may improve the HPV screening coverage. This study aims to evaluate the clinical performance of a newly developed urine/vaginal self-sampling hrHPV test in Cervical cancer screening.

Conditions

  • Human Papillomavirus Infection
  • Cervical Cancer
  • Negative For Intraepithelial Lesion Or Malignancy
  • Atypical Squamous Cells of Undetermined Significance
  • Atypical Squamous Cells, Cannot Rule Out High-grade Squamous Intraepithelial Lesion
  • Cervical Squamous Intraepithelial Lesion
  • Low-Grade Squamous Intraepithelial Lesions
  • 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

  • BeijingNewBiorayTechnologyCo.,Ltd.

    collaborator UNKNOWN
  • Hangzhou Newhorizon Health Technology Co., Ltd.

    collaborator UNKNOWN
  • Peking University People's Hospital

    lead OTHER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-19
Primary Completion
2026-07-31
Completion
2027-08-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05613283 on ClinicalTrials.gov