CervIcal Cancer Screening Trial by Randomization of HPV Testing Intervention for Upcoming Screening (CITRUS Study)

Overview

The aim of this study is to assess efficacy of the screening with concurrent liquid-based cytology and HPV DNA testing for the primary cervical cancer screening over 7 years.

Full Title of Study: “Randomized Controlled Trial to Evaluate the Efficacy of Concurrent Liquid-based Cytology ( LBC) and HPV DNA Testing Versus LBC Alone for the Primary Cervical Cancer Screening”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2021

Interventions

  • Other: LBC
    • Cervical cancer screening by using liquid based cytology as a standard screening modality
  • Other: LBC plus HPV DNA testing
    • Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality

Arms, Groups and Cohorts

  • Active Comparator: LBC
    • Cervical cancer screening by using liquid based cytology as a standard screening modality
  • Experimental: LBC plus HPV DNA testing
    • Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality

Clinical Trial Outcome Measures

Primary Measures

  • The incidence of cervical intraepithelial neoplasia(CIN)3 or worse during the whole period
    • Time Frame: 6 years

Secondary Measures

  • The incidence of CIN3 or worse at baseline, and two years, four years, and six years post baseline
    • Time Frame: 2 years, 4 years, 6 years
  • The incidence of CIN2 or worse at baseline, and two years, four years, and six years post baseline
    • Time Frame: 2 years, 4 years, 6 years
  • The incidence of CIN1 or worse at baseline, and two years, four years, and six years post baseline
    • Time Frame: 2 years, 4 years, 6 years
  • The incidence of invasive cancer at baseline, and two years, four years, and six years post baseline
    • Time Frame: 2 years, 4 years, 6 years
  • The number of cervical cytology performance
    • Time Frame: 6 years
  • The number of colposcopy and biopsy performance
    • Time Frame: 6 years

Participating in This Clinical Trial

Inclusion Criteria

1. Women aged 30-64 years old

2. Participants provided written informed consent

Exclusion Criteria

Women who

1. will receive planed HPV DNA testing by local governmental cervical cancer program next six years

2. have had cervical invasive cancer before

3. have undergone cervical conization

4. have undergone hysterectomy

5. have had or have the cytological abnormalities and are under follow-up

6. are pregnant

7. are judged ineligible for this trial by physician

Gender Eligibility: Female

Minimum Age: 30 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
  • Collaborator
    • Keio University
  • Provider of Information About this Clinical Study
    • Sponsor

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