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

• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01895517
• Collaborator: Keio University (Other), Jikei University School of Medicine (Other)
• Enrollment: 18,471
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 116.8
• Patients Per Site Per Month: 158.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer	Other: LBC; Other: LBC plus HPV DNA testing	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 18471 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• 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
• Actual Study Start Date: Jun 7, 2013
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: LBC Cervical cancer screening by using liquid based cytology as a standard screening modality	Other: LBC; Cervical cancer screening by using liquid based cytology as a standard screening modality
Experimental: LBC plus HPV DNA testing Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality	Other: LBC plus HPV DNA testing; Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality

Outcome Measures

Primary Outcome Measures

1. The incidence of cervical intraepithelial neoplasia(CIN)3 or worse during the whole period [6 years]

Secondary Outcome Measures

1. The incidence of CIN3 or worse at baseline, and two years, four years, and six years post baseline [2 years, 4 years, 6 years]

2. The incidence of CIN2 or worse at baseline, and two years, four years, and six years post baseline [2 years, 4 years, 6 years]

3. The incidence of CIN1 or worse at baseline, and two years, four years, and six years post baseline [2 years, 4 years, 6 years]

4. The incidence of invasive cancer at baseline, and two years, four years, and six years post baseline [2 years, 4 years, 6 years]

5. The number of cervical cytology performance [6 years]

6. The number of colposcopy and biopsy performance [6 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 64 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Medicine, Keio University	Shinjuku	Tokyo	Japan	160-8582

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• ClinicalTrials.gov Identifier: NCT01895517
• Other Study ID Numbers: TRIUC1312; UMIN000010843
• First Posted: Jul 10, 2013
• Last Update Posted: May 25, 2022
• Last Verified: May 1, 2022

• Additional relevant MeSH terms: Uterine Cervical Neoplasms

Study Results

No Results Posted as of May 25, 2022