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BMC Cancer - open access
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 http://ovariancancerandus.blogspot.com/feeds/posts/default
Background Estimating 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/Design A 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.
Discussion We 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 registration ClinicalTrials.gov: registration number NCT02218502
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