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

Phase 4

Completed

• Conditions: Cervical Cancer
• Interventions: Other: LBC plus HPV DNA testing; Other: LBC

• Registration Number: NCT01895517
• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-07
• Study First Submitted: 2013-07-04
• Study First Submitted QC: 2013-07-04
• Study First Posted: 2013-07-10
• Status Verified: 2022-05
• Primary Completion: 2022-11-30
• Study Completion: 2023-05-31
• Last Update Submitted: 2023-06-22
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18471

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LBC plus HPV DNA testing	LBC plus HPV DNA testing	Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality
LBC	LBC	Cervical cancer screening by using liquid based cytology as a standard screening modality

Primary Outcome Measures

Name	Time	Method
The incidence of cervical intraepithelial neoplasia(CIN)3 or worse during the whole period	6 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

School of Medicine, Keio University; 🇯🇵 Shinjuku, Tokyo, Japan