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

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

Status and phase: Completed; Phase 4

Conditions: Cervical Cancer

Treatments: Other: LBC plus HPV DNA testing; Other: LBC

Study type: Interventional

Funder types: Other

Identifiers

NCT01895517

TRIUC1312

UMIN000010843 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 18,471 patients

Sex: Female

Ages: 30 to 64 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18,471 participants in 2 patient groups

LBC

Active Comparator group

Description:

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

Treatment:

Other: LBC

LBC plus HPV DNA testing

Experimental group

Description:

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

Treatment:

Other: LBC plus HPV DNA testing