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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01895517

Enrollment

18471

Registered

2013-07-10

Start date

2013-06-07

Completion date

2023-05-31

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

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.

Interventions

OTHERLBC

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

OTHERLBC plus HPV DNA testing

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 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 number of cervical cytology performance	6 years
The number of colposcopy and biopsy performance	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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026