Investigating the performance and cost-effectiveness of the simple ultrasound-based rules compared to the risk of malignancy index in the diagnosis of ovarian cancer (SUBSONiC-study): protocol of a prospective multicenter cohort study in the Netherlands

BMC Cancer

Study Protocol

Martin GM Bergmans¹  Iris JG Rutten²  Roy FPM Kruitwagen²  Toon van Gorp²  Brigitte F Slangen²  Evelyne MJ Meys²  Helen JMM Mertens³  Ernst Nolting⁴  Dieuwke Boskamp⁵  Regina GH Beets-Tan⁶ 

[1] Department of Obstetrics and Gynecology, Laurentius Ziekenhuis Roermond, PO Box 920,, Mgr. Driessenstraat 6, 6040 AX, Roermond, The Netherlands;Department of Obstetrics and Gynecology, Maastricht University Medical Centre (MUMC+), P. Debyelaan 25, 6202 AZ, Maastricht, The Netherlands;GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre (MUMC+), P. Debyelaan 25, 6202 AZ, Maastricht, The Netherlands;Department of Obstetrics and Gynecology, Orbis Medical Centre Sittard, PO Box 5500,, Dr. H. van der Hoffplein 1, 6130 MB, Sittard, The Netherlands;Department of Obstetrics and Gynecology, St. Jans Gasthuis Weert, PO Box 29,, Vogelsbleek 5, 6000 AA, Weert, The Netherlands;Department of Obstetrics and Gynecology, VieCuri Venlo, PO Box 1926,, Tegelseweg 210, 5900 BX, Venlo, The Netherlands;GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre (MUMC+), P. Debyelaan 25, 6202 AZ, Maastricht, The Netherlands;Department of Radiology, Maastricht University Medical Centre (MUMC+), P. Debyelaan 25, 6202 AZ, Maastricht, The Netherlands;

关键词: Ovarian cancer;    Ultrasound;    Risk of malignancy index;    Simple ultrasound-based rules;    Subjective assessment;    Diffusion weighted imaging;    MRI;    Diagnosis;   

DOI  :  10.1186/s12885-015-1319-5

 received in 2014-08-21, accepted in 2015-04-16,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundEstimating the risk of malignancy is essential in the management of adnexal masses. An accurate differential diagnosis between benign and malignant masses will reduce morbidity and costs due to unnecessary operations, and will improve referral to a gynecologic oncologist for specialized cancer care, which improves outcome and overall survival. The Risk of Malignancy Index is currently the most commonly used method in clinical practice, but has a relatively low diagnostic accuracy (sensitivity 75–80 % and specificity 85–90 %). Recent reports show that other methods, such as simple ultrasound-based rules, subjective assessment and (Diffusion Weighted) Magnetic Resonance Imaging might be superior to the RMI in the pre-operative differentiation of adnexal masses.Methods/DesignA prospective multicenter cohort study will be performed in the south of The Netherlands. A total of 270 women diagnosed with at least one pelvic mass that is suspected to be of ovarian origin who will undergo surgery, will be enrolled. We will apply the Risk of Malignancy Index with a cut-off value of 200 and a two-step triage test consisting of simple ultrasound-based rules supplemented -if necessary- with either subjective assessment by an expert sonographer or Magnetic Resonance Imaging with diffusion weighted sequences, to characterize the adnexal masses. The histological diagnosis will be the reference standard. Diagnostic performances will be expressed as sensitivity, specificity, positive and negative predictive values and likelihood ratios.DiscussionWe hypothesize that this two-step triage test, including the simple ultrasound-based rules, will have better diagnostic accuracy than the Risk of Malignancy Index and therefore will improve the management of women with adnexal masses. Furthermore, we expect this two-step test to be more cost-effective. If the hypothesis is confirmed, the results of this study could have major effects on current guidelines and implementation of the triage test in daily clinical practice could be a possibility.Trial registrationClinicalTrials.gov: registration number NCT02218502

【 授权许可】

Unknown   
© Meys et al. 2015. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.