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

June 22, 2023 updated by: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18471

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Shinjuku, Tokyo, Japan, 160-8582
        • School of Medicine, Keio University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LBC
Cervical cancer screening by using liquid based cytology as a standard screening modality
Other: 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
Other: LBC plus HPV DNA testing
Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
2 years, 4 years, 6 years
The number of cervical cytology performance
Time Frame: 6 years
6 years
The number of colposcopy and biopsy performance
Time Frame: 6 years
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Collaborators

Keio University
Jikei University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2013

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

July 4, 2013

First Submitted That Met QC Criteria

July 4, 2013

First Posted (Estimated)

July 10, 2013

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIUC1312
  • UMIN000010843 (Registry Identifier: UMIN Clinical Trials Registry (UMIN-CTR))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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