An investigation of the benefits of HPV co-testing for cervical cancer screening in Hokkaido
Not Applicable
- Conditions
- cervical cancer and cervical intraepithelial neoplasia
- Registration Number
- JPRN-UMIN000013203
- Lead Sponsor
- Department of Gynecology, Hokkaido University Graduate School of Medicine
- Brief Summary
We conducted a 3-year prospective study with14,644 women undergoing routine screening. Conventional cytology and HPV testing were carried out. Women with abnormal cytology or HPV 16/18 positive underwent colposcopy. Those with 12 other high-risk(hr) HPV types underwent repeat cytology after 6 months. HPV 16/18 were detected in 8/8 (100%) invasive cervical cancers, 2/2 (100%) adenocarcinomas in situ. This study suggested the role of partial genotyping and cytology in an HPV based screening program.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 14644
Inclusion Criteria
Not provided
Exclusion Criteria
1. Women who did not consent. 2. Women less than 20 years old 3. Women over 70 years old 4. Women in pregnancy 5. Women who was judged as inappropriate for the study by a doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correspondence of high-risk HPV positivity and HPV16/18 positivity to age, cytological diagnosis (NILM, ASC-US, >=LSIL) and histological diagnosis (>=CIN2, >=CIN3)
- Secondary Outcome Measures
Name Time Method 1. Detection rate of cervical lesion (>=CIN2, >=CIN3) by combined cytology and HPV testing as compared to the rate by cytology only which was done in the same period of the research or previously. 2. Incidence of >=CIN2 or >=CIN3 after 3 years in connection with the HPV testing results