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
Not Applicable
- Conditions
- cervical cancer
- Registration Number
- JPRN-UMIN000010843
- Lead Sponsor
- The Japanese Society of Clinical Cytology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 30000
Inclusion Criteria
Not provided
Exclusion Criteria
1) Women who will receive planed HPV DNA testing by local governmental cervical cancer program next six years. 2) Women who have had cervical invasive cancer before. 3) Women who have underwent cervical conization. 4) Women who have underwent hysterectomy. 5) Women who have had or have the cytological abnormalities and are under follow-up. 6) Pregnant women. 7) Women judged ineligible for this trial by physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of CIN3 or worse during whole periods
- Secondary Outcome Measures
Name Time Method 1) The incidence of CIN3 or worse at baseline, and two years, four years, and six years post baseline 2) The incidence of CIN2 or worse at baseline, and two years, four years, and six years post baseline 3) The incidence of CIN1 or worse at baseline, and two years, four years, and six years post baseline 4) The incidence of invasive cancer at baseline, and two years, four years, and six years post baseline 5) The number of cervical cytology performance 6) The number of colposcopy and biopsy performance