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Completed

NCT Number: NCT01895517

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

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

30 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

School of Medicine, Keio University

Shinjuku, Tokyo, 160-8582, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LBC

Other

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

LBC plus HPV DNA testing

Other

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

Primary outcomes

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

    Time frame: 6 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Jikei University School of Medicine
  • Keio University

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2022
Study completion
2023
First posted
Jul 10, 2013
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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