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

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan18,471 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

18,471

Conditions

Cervical Cancer

Interventions

LBCOTHER

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

LBC plus HPV DNA testingOTHER

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

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

School of Medicine, Keio University

Shinjuku, Tokyo, Japan

Outcomes

Primary Outcomes

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

Time frame: 6 years

Secondary Outcomes

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

Data from ClinicalTrials.gov

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