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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895517
• Other study ID #: TRIUC1312
• Secondary ID: UMIN000010843
• Status: Completed
• Phase: Phase 4
• Start date: June 7, 2013
• Est. completion date: May 31, 2023

Study information

• Verified date: May 2022
• Source: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18471
• Est. completion date: May 31, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Other:
• LBC
Cervical cancer screening by using liquid based cytology as a standard screening modality
• LBC plus HPV DNA testing
Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality

Locations

Country	Name	City	State
Japan	School of Medicine, Keio University	Shinjuku	Tokyo

Sponsors (3)

Lead Sponsor	Collaborator
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan	Jikei University School of Medicine, Keio University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of cervical intraepithelial neoplasia(CIN)3 or worse during the whole period		6 years
Secondary	The incidence of CIN3 or worse at baseline, and two years, four years, and six years post baseline		2 years, 4 years, 6 years
Secondary	The incidence of CIN2 or worse at baseline, and two years, four years, and six years post baseline		2 years, 4 years, 6 years
Secondary	The incidence of CIN1 or worse at baseline, and two years, four years, and six years post baseline		2 years, 4 years, 6 years
Secondary	The incidence of invasive cancer at baseline, and two years, four years, and six years post baseline		2 years, 4 years, 6 years
Secondary	The number of cervical cytology performance		6 years
Secondary	The number of colposcopy and biopsy performance		6 years