![]() ![]() For this reason, the risk of malignancy algorithm (ROMA) was developed to incorporate both the sensitivity of serum CA-125 and the specificity of HE4 to yield a better diagnostic performance. Although HE4 is highly specific to ovarian malignancy, it is not as sensitive as serum CA-125. Other biomarkers have been investigated to improve specificity for the diagnosis of ovarian cancer, such as the Human Epididymis Protein 4 or HE4. Although the role of CA-125 in the diagnosis of ovarian cancer is controversial due to its only fair level of sensitivity and poor specificity, it is still widely used in the assessment of women with adnexal masses and is routinely used in preoperative investigation. Serum cancer antigen 125 or CA-125 is a well-known biomarker for epithelial ovarian cancer. However, this strategy requires the availability of experienced examiners in the same setting to avoid unnecessary referrals and to reduce the health care costs. A “two-step strategy” using the IOTA Simple Rules with the addition of subjective assessment for masses with inconclusive results was proposed and proved to have excellent test performance comparable to that of subjective assessment alone. According to previous reports, the proportion of inconclusive results could be as high as 20%. The main disadvantage of the IOTA Simple Rules is the possibility of inconclusive results when they do not apply. Many multi-national external validation studies have confirmed the robustness of the accuracy of the IOTA Simple Rules and the IOTA logistic regression models. They provide easy-to-use guidance to non-expert sonographers for making an accurate presurgical diagnosis. The IOTA models carry important advantages over subjective assessments in terms of objectivity, simplicity, and applicability. However, there are still major limitations with the subjectivity of such a method and the lack of expert examiners in most settings. ![]() It has been proved superior to other widely advocated methods such as the Risk of Malignancy Index (RMI), the International Ovarian Tumor Analysis (IOTA) Simple Rules, and IOTA logistic regression models. To date, this is widely accepted that the most accurate approach for the preoperative diagnosis of adnexal masses is subjective assessment (SA) by an experienced sonographer. It is currently the only imaging modality recommended by the American College of Obstetricians and Gynecologists (ACOG) to evaluate adnexal masses in women. Transvaginal ultrasonography is generally the first modality used by gynecologists to characterize these masses in practice. Misclassification in either direction could ultimately lead to a decrease in patient survival, or serious morbidity and unnecessary infertility from overly radical surgery. In contrast, women with benign masses can be managed conservatively or with a minimally invasive approach (e.g., laparoscopic surgery), which can be safely performed by general gynecologists. Women with malignant masses should be referred to gynecologic oncologists for proper surgical staging and optimal debulking surgery. ![]() General gynecologists are required to provide an accurate differentiation between benign and malignant adnexal pathologies to ensure an optimal starting point in the whole chain of care, as this would lead to appropriate decisions regarding the referral of patients to specialized oncologic care. Conclusions: The IOTA SR X CA-125 model showed high discriminative ability and is potentially useful as a decision tool for guiding patient referrals to oncologic specialists. The model that included information from the IOTA Simple Rules and serum CA-125 was significantly more superior to the model that used only information from the IOTA Simple Rules (AuROC 0.95 vs. Results: One hundred and forty-five women (30.3%) out of a total of 479 with adnexal masses had malignant ovarian tumors. Evaluation of the diagnostic added-value was based on the increment of the area under the receiver operating characteristic curve (AuROC). Logistic regression was used for development of the model. Histopathologic diagnosis was used as the reference standard. Demographic and clinical data were prospectively collected. Methods: A secondary analysis of a cross-sectional cohort of women scheduled for surgery in Maharaj Nakorn Chiang Mai Hospital between April 2010 and March 2018 was carried out. Background: This study aimed to evaluate the diagnostic added-value of serum CA-125 to the International Ovarian Tumor Analysis (IOTA) Simple Rules in order to facilitate differentiation between malignant and benign ovarian tumors before surgery. ![]()
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