NCT01895517

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,471

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 7, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

June 26, 2023

Status Verified

May 1, 2022

Enrollment Period

9.5 years

First QC Date

July 4, 2013

Last Update Submit

June 22, 2023

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

  • The incidence of cervical intraepithelial neoplasia(CIN)3 or worse during the whole period

    6 years

Secondary Outcomes (6)

  • The incidence of CIN3 or worse at baseline, and two years, four years, and six years post baseline

    2 years, 4 years, 6 years

  • The incidence of CIN2 or worse at baseline, and two years, four years, and six years post baseline

    2 years, 4 years, 6 years

  • The incidence of CIN1 or worse at baseline, and two years, four years, and six years post baseline

    2 years, 4 years, 6 years

  • The incidence of invasive cancer at baseline, and two years, four years, and six years post baseline

    2 years, 4 years, 6 years

  • The number of cervical cytology performance

    6 years

  • +1 more secondary outcomes

Study Arms (2)

LBC

ACTIVE COMPARATOR

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

Other: LBC

LBC plus HPV DNA testing

EXPERIMENTAL

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

Other: LBC plus HPV DNA testing

Interventions

LBCOTHER

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

LBC
LBC plus HPV DNA testingOTHER

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

LBC plus HPV DNA testing

Eligibility Criteria

Age30 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 30-64 years old
  • Participants provided written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Medicine, Keio University

Shinjuku, Tokyo, 160-8582, Japan

Location

Related Publications (1)

  • 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.

    PMID: 28818742DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

AKAP13 protein, human

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2013

First Posted

July 10, 2013

Study Start

June 7, 2013

Primary Completion

November 30, 2022

Study Completion

May 31, 2023

Last Updated

June 26, 2023

Record last verified: 2022-05

Locations

JP(1)