Efficacy of addition of high-risk human papillomavirus (hrHPV) testing by Hybrid Capture II to conventional cytological screening for cervical cancer
| ISRCTN | ISRCTN64621295 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64621295 |
| Protocol serial number | NTR215; 2002/02WBO |
| Sponsor | SALTRO - Doctor Laboratory & Thrombosis Service (The Netherlands) |
| Funders | Vrije University Medical Centre (VUMC) (The Netherlands) - Department of Pathology, SALTRO - Doctor Laboratory & Thrombosis Service (The Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 19/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
SALTRO
Mississippidreef 83
P.O. Box 9300
Utrecht
3565 CE
Netherlands
| Phone | +31 (0)30 236 1136 |
|---|---|
| m.herreilers@saltro.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised triple-blinded active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | VUSABOB |
| Study objectives | 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(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 01/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 25000 |
| Key inclusion criteria | 1. Women invited for the cervical cancer screening program (aged 30 - 60 years) 2. General practitioner affiliated with SALTRO laboratory |
| Key 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 |
| Date of first enrolment | 01/10/2003 |
| Date of final enrolment | 01/12/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
3565 CE
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
