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

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 - Cervical cancer screening trial by randomization of HPV testing intervention for upcoming screening (CITRUS study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010843

Enrollment

30000

Registered

2013-06-01

Start date

2013-06-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

cervical cancer

Interventions

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 experimentary screening mo

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Women aged 30-64 years old. 2) Participants provided written informed consent.

Exclusion criteria

Exclusion criteria: 1) Women who will receive planed HPV DNA testing by local governmental cervical cancer program next six years. 2) Women who have had cervical invasive cancer before. 3) Women who have underwent cervical conization. 4) Women who have underwent hysterectomy. 5) Women who have had or have the cytological abnormalities and are under follow-up. 6) Pregnant women. 7) Women judged ineligible for this trial by physician.

Design outcomes

Primary

Measure	Time frame
The incidence of CIN3 or worse during whole periods	—

Secondary

Measure	Time frame
1) The incidence of CIN3 or worse at baseline, and two years, four years, and six years post baseline 2) The incidence of CIN2 or worse at baseline, and two years, four years, and six years post baseline 3) The incidence of CIN1 or worse at baseline, and two years, four years, and six years post baseline 4) The incidence of invasive cancer at baseline, and two years, four years, and six years post baseline 5) The number of cervical cytology performance 6) The number of colposcopy and biopsy performance	—

Measure

Time frame

1) The incidence of CIN3 or worse at baseline, and two years, four years, and six years post baseline 2) The incidence of CIN2 or worse at baseline, and two years, four years, and six years post baseline 3) The incidence of CIN1 or worse at baseline, and two years, four years, and six years post baseline 4) The incidence of invasive cancer at baseline, and two years, four years, and six years post baseline 5) The number of cervical cytology performance 6) The number of colposcopy and biopsy performance

—

Countries

Japan

Contacts

Public ContactDaisuke Aoki

School of Medicine, Keio University Department of Obstetrics and Gynecology

aoki@z7.keio.jp03-3353-1211(62391)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026