- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01895517
CervIcal Cancer Screening Trial by Randomization of HPV Testing Intervention for Upcoming Screening (CITRUS Study)
June 22, 2023 updated by: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18471
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tokyo
-
Shinjuku, Tokyo, Japan, 160-8582
- School of Medicine, Keio University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Women aged 30-64 years old
- Participants provided written informed consent
Exclusion Criteria:
Women who
- will receive planed HPV DNA testing by local governmental cervical cancer program next six years
- have had cervical invasive cancer before
- have undergone cervical conization
- have undergone hysterectomy
- have had or have the cytological abnormalities and are under follow-up
- are pregnant
- are judged ineligible for this trial by physician
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: LBC
Cervical cancer screening by using liquid based cytology as a standard screening modality
|
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
|
Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of cervical intraepithelial neoplasia(CIN)3 or worse during the whole period
Time Frame: 6 years
|
6 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of CIN3 or worse at baseline, and two years, four years, and six years post baseline
Time Frame: 2 years, 4 years, 6 years
|
2 years, 4 years, 6 years
|
The incidence of CIN2 or worse at baseline, and two years, four years, and six years post baseline
Time Frame: 2 years, 4 years, 6 years
|
2 years, 4 years, 6 years
|
The incidence of CIN1 or worse at baseline, and two years, four years, and six years post baseline
Time Frame: 2 years, 4 years, 6 years
|
2 years, 4 years, 6 years
|
The incidence of invasive cancer at baseline, and two years, four years, and six years post baseline
Time Frame: 2 years, 4 years, 6 years
|
2 years, 4 years, 6 years
|
The number of cervical cytology performance
Time Frame: 6 years
|
6 years
|
The number of colposcopy and biopsy performance
Time Frame: 6 years
|
6 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 7, 2013
Primary Completion (Actual)
November 30, 2022
Study Completion (Actual)
May 31, 2023
Study Registration Dates
First Submitted
July 4, 2013
First Submitted That Met QC Criteria
July 4, 2013
First Posted (Estimated)
July 10, 2013
Study Record Updates
Last Update Posted (Actual)
June 26, 2023
Last Update Submitted That Met QC Criteria
June 22, 2023
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Uterine Cervical Neoplasms
Other Study ID Numbers
- TRIUC1312
- UMIN000010843 (Registry Identifier: UMIN Clinical Trials Registry (UMIN-CTR))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Cancer
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University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
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M.D. Anderson Cancer CenterWithdrawnStage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical Cancer FIGO 2018 | Stage IIB Cervical Cancer FIGO 2018 | Stage III Cervical Cancer FIGO 2018 | Stage IIIA Cervical Cancer FIGO... and other conditions
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Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
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National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
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Mayo ClinicNational Cancer Institute (NCI)RecruitingCervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Recurrent Cervical Carcinoma | Stage IB3 Cervical Cancer FIGO 2018 | Stage II Cervical Cancer FIGO 2018 | Stage IIA Cervical Cancer FIGO 2018 | Stage IIA1 Cervical Cancer FIGO 2018 | Stage IIA2 Cervical... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
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Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
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Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
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