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Diagnostic accuracy of the ThinPrep liquid based versus conventional cytology.


- candidate number2685
- NTR NumberNTR1032
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-jul-2007
- Secondary IDsEU/CVZ nummer 
- Public TitleDiagnostic accuracy of the ThinPrep liquid based versus conventional cytology.
- Scientific TitleDiagnostic accuracy, adequacy and cost-effectiveness of ThinPrep method in primary screening.
- ACRONYMNethon
- hypothesisThere 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.
- Healt Condition(s) or Problem(s) studiedCervix cancer, Liquid based cytology, Conventional cytology, ThinPrep, Cervical cancer screening
- Inclusion criteriaWomen, participating in the national cervical screening program, recruited from family practices who were randomised to experimental arm (ThinPrep) or control arm (conventional cytology).
- Exclusion criteriaN/A
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2003
- planned closingdate31-dec-2008
- Target number of participants90000
- InterventionsComparing performance of ThinPrep with conventional cytology.
- Primary outcome1. Cost effectiveness in terms of incremental cost per additional abnormal case detected;
2. Costs per invasive cancer prevented and life years gained.
- Secondary outcomeDiagnostic accuracy in terms of detection rate ratios of cervical intraepithelial neoplasia and cancer, gain in sensitivity and positive predictive value.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESPathologist J. Bulten
- CONTACT for SCIENTIFIC QUERIESPathologist J. Bulten
- Sponsor/Initiator University Medical Center St. Radboud, Department of Pathology
- Funding
(Source(s) of Monetary or Material Support)
National Institute of Public Health and Environmental Protection (RIVM), European Network for Cervical Cancer Screening, European Cancer Network
- PublicationsCytological detection of cervical abnormalities with the ThinPrep liquid based versus conventional cytology: population based randomised controlled trial.
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD31-jul-2007 - 28-apr-2008


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