| - candidate number | 2685 |
| - NTR Number | NTR1032 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 31-jul-2007 |
| - Secondary IDs | EU/CVZ nummer |
| - Public Title | Diagnostic accuracy of the ThinPrep liquid based versus conventional cytology. |
| - Scientific Title | Diagnostic accuracy, adequacy and cost-effectiveness of ThinPrep method in primary screening. |
| - ACRONYM | Nethon |
| - hypothesis | 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. |
| - Healt Condition(s) or Problem(s) studied | Cervix cancer, Liquid based cytology, Conventional cytology, ThinPrep, Cervical cancer screening |
| - 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 |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-apr-2003 |
| - planned closingdate | 31-dec-2008 |
| - Target number of participants | 90000 |
| - Interventions | Comparing performance of ThinPrep with conventional cytology. |
| - 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. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Pathologist J. Bulten |
| - CONTACT for SCIENTIFIC QUERIES | Pathologist 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 |
| - Publications | Cytological detection of cervical abnormalities with the ThinPrep liquid based versus conventional cytology: population based randomised controlled trial. |
| - Brief 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. |
| - Main changes (audit trail) | |
| - RECORD | 31-jul-2007 - 28-apr-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl