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.
Conditions
Sponsors
- Department of Pathology, VU University Medical Center
- Department of Pathology, Spaarne Ziekenhuis, Hoofddorp
- Leiden Cytology and Pathology Laboratory, Leiden
- Stichting PA Laboratorium Kennemerland, Haarlem
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women invited for the cervical cancer screening program (ages 30-60 years); 2. Residing in either the region covered by district health authority Amstelland-de Meerlanden and Zuid-Kennemerland.
Exclusion criteria
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 CIN lesions less than 2 years before inclusion; 3. Status after extirpation of the uterus or amputation of the portio.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure of POBASCAM trial is the occurrence of histologically confirmed cervical intra-epithelial neoplasia grade 3 (CIN3) lesions or (micro-) invasive carcinoma of the cervix found during the time span from intake up to and including the next screening round, i.e., in 5 years. Since women with normal cytology at the next screening round will not be referred for colposcopically-directed biopsies and therefore will not have a histological endpoint, it will be assumed that no precursor lesions of cervical cancer are present. This policy complies with regular cervical screening in The Netherlands. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactN.W.J. Bulkmans
VU University Medical Center, Department of Pathology, De Boelelaan 1117
Outcome results
None listed