Primary Cervical Cancer Screening by Self-sampling HPV Test

Last updated: December 19, 2023
Sponsor: Peking University People's Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cervical Cancer

Adenocarcinoma

Cervical Intraepithelial Neoplasia

Treatment

N/A

Clinical Study ID

NCT05613283
NH-3004
  • Ages 21-65
  • Female
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • a. Females aged 21-65; b. have a history of sexual life; c. The patients werevoluntarily enrolled and signed the informed consent.

Exclusion

Exclusion Criteria:

  • Accuracy Verification: Subjects meeting any of the following criteria will be excluded:
  1. Known pregnant subjects.
  2. Participants who have undergone total hysterectomy.
  3. Participants who have received cervical resection therapy or ablative therapy within 12 months, such as cryo, laser, microwave, coagulation, cryotherapy, LEEP, large loopelectrosurgery (LLETZ), cold knife conization (CKC), laser conization, or ablation.
  4. Participants with poor compliance or researchers who believe that they are notsuitable to participate in this study.
  • Primary screening use: Subjects meeting any of the following criteria will be excluded:
  1. Known pregnant subjects.
  2. Participants who have undergone total hysterectomy.
  3. Participants who have received cervical resection therapy or ablative therapy within 12 months, such as cryo, laser, microwave, coagulation, cryotherapy, LEEP, large loopelectrosurgery (LLETZ), cold knife conization (CKC), laser conization, or ablation.
  4. Those with known history of cervical cancer.
  5. Participants who participated in cervical cancer screening programs or underwentcervical cytology within 12 months.
  6. Participants with poor compliance or researchers who believe that they are notsuitable to participate in this study.

Study Design

Total Participants: 17875
Study Start date:
November 19, 2022
Estimated Completion Date:
August 31, 2027

Study Description

This study is a prospective multi-center clinical trial in China. Eligible participants are cervical cancer screening population who meet the enrollment criterias. All the participants are required to provide urine and vaginal samples by self-sampling, as well as the cervical exfoliated cell samples (by HCP). Participants may undergo colposcopy examination depending on the test results, and they will be followed up for three years.

The high-risk human papillomavirus nucleic acid detection kit (PCR-fluorescent probe method) developed by New Horizon Co., Ltd . is suitable for in vitro qualitative detection of 14 types of high-risk HPV ( 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) nucleic acid.

The clinical performance of the self-sampling test will be assessed base on the following outcomes:

  1. The sensitivity for detecting CIN2+

  2. The specificity in non-CIN2+ population

  3. The risk of developing CIN2+ in test positive cohort and test negative cohort

  4. The accuracy of detecting hrHPV

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • The Third Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Site Not Available

  • Hunan Provincial Maternal and Child Health Care Hospital

    Changsha, Hunan
    China

    Site Not Available

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan
    China

    Site Not Available

  • Women's Hospital School Of Medicine Zhejiang University

    Hangzhou, Zhejiang
    China

    Site Not Available

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