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

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ClinicalTrials.gov Identifier: NCT01895517
Recruitment Status : Active, not recruiting
First Posted : July 10, 2013
Last Update Posted : April 4, 2019
Sponsor:
Collaborators:
Keio University
Jikei University School of Medicine
Information provided by (Responsible Party):
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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

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Study Type : Interventional  (Clinical Trial)
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 : June 7, 2013
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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




Primary Outcome Measures :
  1. The incidence of cervical intraepithelial neoplasia(CIN)3 or worse during the whole period [ Time Frame: 6 years ]

Secondary Outcome Measures :
  1. 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. 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 ]
  3. 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 ]
  4. 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 ]
  5. The number of cervical cytology performance [ Time Frame: 6 years ]
  6. The number of colposcopy and biopsy performance [ Time Frame: 6 years ]


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Ages Eligible for Study:   30 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895517


Locations
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Japan
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT01895517     History of Changes
Other Study ID Numbers: TRIUC1312
UMIN000010843 ( Registry Identifier: UMIN Clinical Trials Registry (UMIN-CTR) )
First Posted: July 10, 2013    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female