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

T

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

Status and phase

Completed
Phase 4

Conditions

Cervical Cancer

Treatments

Other: LBC plus HPV DNA testing
Other: LBC

Study type

Interventional

Funder types

Other

Identifiers

NCT01895517
TRIUC1312
UMIN000010843 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

18,471 patients

Sex

Female

Ages

30 to 64 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

18,471 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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