No registrations found.
ID
Source
Brief title
Health condition
1. Cervical cancer screening;
2. liquid based cytology;
3. ThinPrep;
4. conventional cytology.
Sponsors and support
European Cancer Network and the Dutch Ministery of Health, through the National Institute for Public Health and Environment.
Intervention
Outcome measures
Primary outcome
1. Cost effectiveness in terms of incremental cost per additional abnormal case detected;
2. Costs per invasive cancer prevented and life years gained.
Secondary outcome
Diagnostic accuracy in terms of detection rate ratios of cervical intraepithelial neoplasia and cancer, gain in sensitivity and positive predictive value.
Background summary
In this trial, cost-effectiveness and accuracy of the liquid-based ThinPrep cytology is compared with conventional cytology. The two-centre, cluster randomized controlled trial is performed within the national cervical screening program and includes 90.000 participants. The results of this trial will be helpful to determine whether implementation in the national cervical screeningprogram will be useful.
Study objective
There are clues that the ThinPrep method has a higher detection of cervical epithelial abnormalities. A cost-effectiveness study is needed to determine whether implementation in the Dutch national cervical screening program is useful.
Study design
N/A
Intervention
Comparing performance of ThinPrep with conventional cytology.
Dept of Pathology
PO Box 9101,
huispost 824
J. Bulten
Nijmegen 6500 HB
The Netherlands
+31 (0)24-3614323
h.bulten@pathol.umcn.nl
Dept of Pathology
PO Box 9101,
huispost 824
J. Bulten
Nijmegen 6500 HB
The Netherlands
+31 (0)24-3614323
h.bulten@pathol.umcn.nl
Inclusion criteria
Women, participating in the national cervical screening program, recruited from family practices who were randomised to experimental arm (ThinPrep) or control arm (conventional cytology).
Exclusion criteria
N/A
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1003 |
| NTR-old | NTR1032 |
| Other | : EU/CVZ nummer |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |