Overview

This trial is active, not recruiting.

Condition cervical cancer
Treatments lbc, lbc plus hpv dna testing
Phase phase 4
Sponsor Translational Research Informatics Center, Kobe, Hyogo, Japan
Collaborator Keio University
Start date June 2013
End date March 2020
Trial size 18471 participants
Trial identifier NCT01895517, TRIUC1312, UMIN000010843

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose screening
Arm
(Active Comparator)
Cervical cancer screening by using liquid based cytology as a standard screening modality
lbc
Cervical cancer screening by using liquid based cytology as a standard screening modality
(Experimental)
Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality
lbc plus hpv dna testing
Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality

Primary Outcomes

Measure
The incidence of cervical intraepithelial neoplasia(CIN)3 or worse during the whole period
time frame: 6 years

Secondary Outcomes

Measure
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
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
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
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
The number of cervical cytology performance
time frame: 6 years
The number of colposcopy and biopsy performance
time frame: 6 years

Eligibility Criteria

Female participants from 30 years up to 64 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Translational Research Informatics Center, Kobe, Hyogo, Japan.