Efficacy of addition of high-risk human papillomavirus (hrHPV) testing by Hybrid Capture II to conventional cytological screening for cervical cancer
Completed
- Conditions
- Cervical intraepithelial neoplasiaCarcinoma in situ of cervix uteriCancer
- Registration Number
- ISRCTN64621295
- Lead Sponsor
- SALTRO - Doctor Laboratory & Thrombosis Service (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 25000
Inclusion Criteria
1. Women invited for the cervical cancer screening program (aged 30 - 60 years)
2. General practitioner affiliated with SALTRO laboratory
Exclusion Criteria
1. Not called for screening, i.e., ages under 30 years, or over 60 years
2. Follow-up of previous non-normal cytology within the current screening round of the program, i.e., abnormal cytology or lesion greater than or equal to CIN3 less than 2 years before inclusion
3. Current pregnancy
4.Status after extirpation of the uterus or amputation of the portio
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure of VUSABOB is the occurrence of histologically confirmed cervical intra-epithelial neoplasia grade 3 (CIN3) lesions or (micro-) invasive carcinoma of the cervix found during the follow-up of currently diagnosed abnormalties, i.e., within 2 years. For women whose cytology results either regress to normal (in the unblinded trial of women with mild cytological abnormalities) or who clear an infection with hrHPV without cytological abnormalities (in the blinded trial of women with normal cytology diagnoses), we assume that no precursor lesions of cervical cancer are present. They will not be referred for colposcopically-directed biopsies and therefore will not have a histological endpoint. This policy complies with regular cervical screening in The Netherlands.
- Secondary Outcome Measures
Name Time Method As a secondary outcome measure, histologically confirmed cervical intra-epithelial neoplasia grade 2 will also be investigated, since current guidelines recommend ablative treatment for these lesions as well. Other secondary parameters obtained include progression and regression of cytology diagnoses, clearance and acquisition of hrHPV infections and the number of referrals for colposcopically-directed biopsies.