Philadelphia, PA, January 19, 2016 - Elsevier Health Sciences -- In a landmark study, investigators from Europe propose a new and simple method to assess the risk of malignancy of women with an adnexal mass. The method identified between 89-99% of patients with ovarian cancer using the results of ultrasound examination, which can be obtained in referral and non-referral centers. The work is based on the "Simple Rules", criteria developed by the International Ovarian Tumor Analysis (IOTA) group to improve accurate diagnosis of ovarian cancer before surgery. Published in the American Journal of Obstetrics and Gynecology, this new approach has the potential to level and raise the playing field and put expert interpretation and improved diagnostic capability within reach of all practitioners.

While ovarian cancer is a common and potentially lethal disease, early detection and treatment improve survival. However, adnexal masses, ovarian masses or cysts that persist and become enlarged, often pose a diagnostic dilemma because preoperative tests to determine if they are benign or malignant are often inconclusive. The IOTA group developed a set of "Simple Rules" based on ultrasound images of the adnexal masses, which allows them to be classified as either benign or malignant.

Although the Simple Rules have been well-received by clinicians, an important question from patients and physicians has been whether it is possible to calculate the individual risk of malignancy for a particular patient. In this study published today, the IOTA group led by Professor Dirk Timmerman, MD, PhD, of the Department of Obstetrics and Gynecology, University Hospitals Leuven, Belgium, sought to develop and validate a model to predict the risk of malignancy in adnexal masses using the ultrasound features derived from the Simple Rules. This study represents the culmination of multiple consecutive multicenter studies involving 22 centers in 10 countries over 13 years (1999 to 2012) and approximately 5,000 patients with adnexal masses.
"The Simple Rules are intuitively attractive because of their ease of use, however, when used as originally suggested, they allow only a categorization of tumors into three groups: benign, malignant, or inconclusive," explained Dr. Timmerman. "In this study we show that the Simple Rules can now be used to estimate the risk of malignancy in every adnexal mass and so can be used for individualized patient management."

In this study, the IOTA investigators examined patients before surgery, using a standardized examination technique and standardized terms and definitions to describe ultrasound findings. The predictions based on ultrasounds were subsequently compared with the histological findings after the tumor was examined by pathologists (gold standard to define if a tumor is benign or malignant). The risk of malignancy was calculated.

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