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

Primary Purpose

Cervical Cancer

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
LBC
LBC plus HPV DNA testing
Sponsored by
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Cancer

Eligibility Criteria

30 Years - 64 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • School of Medicine, Keio University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

LBC

LBC plus HPV DNA testing

Arm Description

Cervical cancer screening by using liquid based cytology as a standard screening modality

Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality

Outcomes

Primary Outcome Measures

The incidence of cervical intraepithelial neoplasia(CIN)3 or worse during the whole period

Secondary Outcome Measures

The incidence of CIN3 or worse at baseline, and two years, four years, and six years post baseline
The incidence of CIN2 or worse at baseline, and two years, four years, and six years post baseline
The incidence of CIN1 or worse at baseline, and two years, four years, and six years post baseline
The incidence of invasive cancer at baseline, and two years, four years, and six years post baseline
The number of cervical cytology performance
The number of colposcopy and biopsy performance

Full Information

First Posted
July 4, 2013
Last Updated
June 22, 2023
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Keio University, Jikei University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01895517
Brief Title
CervIcal Cancer Screening Trial by Randomization of HPV Testing Intervention for Upcoming Screening （CITRUS Study）
Official Title
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
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 7, 2013 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Keio University, Jikei University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18471 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LBC
Arm Type
Active Comparator
Arm Description
Cervical cancer screening by using liquid based cytology as a standard screening modality
Arm Title
LBC plus HPV DNA testing
Arm Type
Experimental
Arm Description
Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality
Intervention Type
Other
Intervention Name(s)
LBC
Intervention Description
Cervical cancer screening by using liquid based cytology as a standard screening modality
Intervention Type
Other
Intervention Name(s)
LBC plus HPV DNA testing
Intervention Description
Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality
Primary Outcome Measure Information:
Title
The incidence of cervical intraepithelial neoplasia(CIN)3 or worse during the whole period
Time Frame
6 years
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
The number of cervical cytology performance
Time Frame
6 years
Title
The number of colposcopy and biopsy performance
Time Frame
6 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women aged 30-64 years old Participants provided written informed consent Exclusion Criteria: Women who will receive planed HPV DNA testing by local governmental cervical cancer program next six years have had cervical invasive cancer before have undergone cervical conization have undergone hysterectomy have had or have the cytological abnormalities and are under follow-up are pregnant are judged ineligible for this trial by physician
Facility Information:
Facility Name
School of Medicine, Keio University
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
28818742
Citation
Morisada T, Teramoto K, Takano H, Sakamoto I, Nishio H, Iwata T, Hashi A, Katoh R, Okamoto A, Sasaki H, Nakatani E, Teramukai S, Aoki D. CITRUS, cervical cancer screening trial by randomization of HPV testing intervention for upcoming screening: Design, methods and baseline data of 18,471 women. Cancer Epidemiol. 2017 Oct;50(Pt A):60-67. doi: 10.1016/j.canep.2017.07.017. Epub 2017 Aug 16.
Results Reference
derived

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

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