Contact information
Type
Scientific
Primary contact
Dr M. Herreilers
ORCID ID
Contact details
SALTRO
Mississippidreef 83
P.O. Box 9300
Utrecht
3565 CE
Netherlands
+31 (0)30 236 1136
m.herreilers@saltro.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR215; 2002/02WBO
Study information
Scientific title
Acronym
VUSABOB
Study hypothesis
1. In this study, we expect to decrease the number of referrals and repeat smears by immediately referring those women who are positive for high-risk human papillomavirus (hrHPV) with mildly abnormal smears for colposcopically-directed biopsies. Thus, for the remaining women with BMD who have tested hrHPV negative, repeat smears will not be necessary.
2. Secondly, we expect to be able to narrowly define a risk group of women within the group with normal cytology, that has an increased risk for the development of high-grade lesions based on the presence of hrHPV in the smear.
The hrHPV negative women with normal smears will be at a decreased risk for the development of high-grade lesions, and for them, the interval between screening smears could be increased (from an interval of 5 years, to an interval of 8 - 10 years).
Ethics approval
Received from local medical ethics committee
Study design
Randomised triple-blinded active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cervical intraepithelial neoplasia
Intervention
In the VUSABOB, the addition of a high-risk human papillomavirus (hrHPV) test, using the commercially available and FDA approved Hybrid Capture II test, to the regular cervical screening programme in order to improve detection of precursor lesions of cervical cancer is evaluated using a cohort study of women whose smears were consecutively screened at a single laboratory in The Netherlands. Within this cohort study, we nested an unblinded trial of women with mildly abnormal screening smears and repeat and referral recommendations were based on the presence or absence of high-risk human papillomavirus.
Secondly, we nested a randomised trial of women with normal cytology whose hrHPV test results were triple blinded to participants, treating clinicians and study personnel, and advised all women with blinded test results to repeat cervical screening at earlier intervals than current screening guidelines in the Netherlands recommend in order to evaluate screening strategies for women with normal cytology and a positive hrHPV test.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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
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.
Overall trial start date
01/10/2003
Overall trial end date
01/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women invited for the cervical cancer screening program (aged 30 - 60 years)
2. General practitioner affiliated with SALTRO laboratory
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
25000
Participant 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
Recruitment start date
01/10/2003
Recruitment end date
01/12/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
SALTRO
Utrecht
3565 CE
Netherlands
Sponsor information
Organisation
SALTRO - Doctor Laboratory & Thrombosis Service (The Netherlands)
Sponsor details
P.O. Box 9300
Utrecht
3506 GH
Netherlands
saltro@saltro.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Vrije University Medical Centre (VUMC) (The Netherlands) - Department of Pathology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
SALTRO - Doctor Laboratory & Thrombosis Service (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary