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

NCT ID: NCT01895517

Last Updated: 2023-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18471 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-07

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LBC

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

Group Type ACTIVE_COMPARATOR

LBC

Intervention Type OTHER

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

Group Type EXPERIMENTAL

LBC plus HPV DNA testing

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LBC

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

Intervention Type OTHER

LBC plus HPV DNA testing

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Keio University

OTHER

Sponsor Role collaborator

Jikei University School of Medicine

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

School of Medicine, Keio University

Shinjuku, Tokyo, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

Morisada T, Teramoto K, Takano H, Sakamoto I, Nishio H, Iwata T, Hashi A, Katoh R, Okamoto A, Sasaki H, Nakatani E, Teramukai S, Aoki D. CITRUS, cervical cancer screening trial by randomization of HPV testing intervention for upcoming screening: Design, methods and baseline data of 18,471 women. Cancer Epidemiol. 2017 Oct;50(Pt A):60-67. doi: 10.1016/j.canep.2017.07.017. Epub 2017 Aug 16.

Reference Type DERIVED
PMID: 28818742 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UMIN000010843

Identifier Type: REGISTRY

Identifier Source: secondary_id

TRIUC1312

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Screening for Early Cervical Cancer Detection
NCT06550583 ACTIVE_NOT_RECRUITING