Efficacy of addition of hrHPV testing by Hybrid Capture II to conventional cytological screening for cervical cancer.
Completed
- Conditions
- Cervical intraepithelial neoplasia and cervical cancer.Due to the low prevalence of invasive cervical cancer in the Netherlands, and the aim of cervical screening to prevent the occurrence of and death caused by to cervical cancer, we evaluate the prevalence of a surrogate marker for cervical cancer incidence, namely the immediate precursor lesion of cervical cancer cervical intra-epithelial neoplasia grade 3.
- Registration Number
- NL-OMON26473
- Lead Sponsor
- - Department of Pathology, VU University Medical Center, Amsterdam- SALTRO Artsenlaboratorium & Trombosedienst, Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25000
Inclusion Criteria
1. Women invited for the cervical cancer screening program (ages 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 ¡ÝCIN3 less than 2 years before inclusion;
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. <br />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. <br />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. <br />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.