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Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass.

ABSTRACT: It is often difficult to distinguish a benign pelvic mass from a malignancy and tools to help referring physician are needed. The purpose of this study was to validate the Risk of Ovarian Malignancy Algorithm in women presenting with a pelvic mass.This was a prospective, multicenter, blinded clinical trial that included women who presented to a gynecologist, a family practitioner, an internist, or a general surgeon with an adnexal mass. Serum HE4 and CA 125 were determined preoperatively. A Risk of Ovarian Malignancy Algorithm score was calculated and classified patients into high-risk and low-risk groups for having a malignancy. The sensitivity, specificity, negative predictive value, and positive predictive value of the Risk of Ovarian Malignancy Algorithm were estimated.A total of 472 patients were evaluated with 383 women diagnosed with benign disease and 89 women with a malignancy. The incidence of all cancers was 15% and 10% for ovarian cancer. In the postmenopausal group, a sensitivity of 92.3% and a specificity of 76.0% and for the premenopausal group the Risk of Ovarian Malignancy Algorithm had a sensitivity of 100% and specificity of 74.2% for detecting ovarian cancer. When considering all women together, the Risk of Ovarian Malignancy Algorithm had a sensitivity of 93.8%, a specificity of 74.9%, and a negative predictive value of 99.0%.The use of the serum biomarkers HE4 and CA 125 with the Risk of Ovarian Malignancy Algorithm has a high sensitivity for the prediction of ovarian cancer in women with a pelvic mass. These findings support the use of the Risk of Ovarian Malignancy Algorithm as a tool for the triage of women with an adnexal mass to gynecologic oncologists.II.

SUBMITTER: Moore RG

PROVIDER: S-EPMC3594110 | biostudies-literature | 2011 Aug

REPOSITORIES: biostudies-literature

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Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass.

Moore Richard G RG Miller M Craig MC Disilvestro Paul P Landrum Lisa M LM Gajewski Walter W Ball John J JJ Skates Steven J SJ

Obstetrics and gynecology 20110801 2 Pt 1

<h4>Objective</h4>It is often difficult to distinguish a benign pelvic mass from a malignancy and tools to help referring physician are needed. The purpose of this study was to validate the Risk of Ovarian Malignancy Algorithm in women presenting with a pelvic mass.<h4>Methods</h4>This was a prospective, multicenter, blinded clinical trial that included women who presented to a gynecologist, a family practitioner, an internist, or a general surgeon with an adnexal mass. Serum HE4 and CA 125 were ...[more]

PMID: 21775843

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Project description:There is no universal screening method for discrimination between benign and malignant adnexal masses yet. Various authors have tried tumor markers, imaging studies, cytology but no one yet is a definite method for screening of cancer ovary, for which a combined diagnostic modality has come to practice in form of RMI. With this background we conducted our study "Evaluation of risk malignancy index and its diagnostic value in patients with adnexal masses".The aim of the study was to determine the effectiveness of risk of malignancy index (RMI-3) in preoperative discrimination between benign and malignant masses and also to reveal the most suitable cut off value. We have conducted a prospective study between November 2014 to October 2016. We included the parameters like menopausal status, ultrasound features, and serum levels of tumor marker like CA-125 for calculating RMI 3. Then RMI was compared with the histopathological report which was taken as gold standard.In the present study malignant tumors constitute 54.76% (69/126) & benign tumors 45.24% (57/126). Bilaterality in adnexal masses and multilocularity is higher in malignant tumors than benign tumor, but a P -value >0.005 failed to be proved significant in our study. Solid area is seen in 24.69% (20/81) of benign and 75.30% (61/81) of malignant tumor. Similarly ascites was found in 38.09% (48/126) of cases. Out of which 18.75% (9/48) cases were found to be benign and malignancy was confirmed in 81.25% (39/48) patients. There is statistically significant number of malignant ovarian cancer patients where ascites and solid area is seen in USG findings (p = 0.000). Risk of Malignancy Index compared with individual parameters of Ultrasound score, CA-125 or menopausal score and a cut-off point of 236 shows a very high sensitivity (72.5%), specificity (98.2%), positive predictive value (98.1%), negative predictive value (74.7%) and diagnostic accuracy (84.13%) for discriminating malignant and benign pelvic masses.Simplicity and applicability of the method in the primary evaluation of patients with pelvic masses makes it a good option in daily clinical practice in non-specialized gynecologic departments and also in developing countries where access to a gynaecologist oncologist is limited.

Project description:BackgroundsRisk for Ovarian Malignancy Algorithm (ROMA) and Human epididymis protein 4 (HE4) appear to be promising predictors for epithelial ovarian cancer (EOC), however, conflicting results exist in the diagnostic performance comparison among ROMA, HE4 and CA125.MethodsRemote databases (MEDLINE/PUBMED, EMBASE, Web of Science, Google Scholar, the Cochrane Library and ClinicalTrials.gov) and full texts bibliography were searched for relevant abstracts. All studies included were closely assessed with the QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies-2). EOC predictive value of ROMA was systematically evaluated, and comparison among the predictive performances of ROMA, HE4 and CA125 were conducted within the same population. Sensitivity, specificity, DOR (diagnostic odds ratio), LR ± (positive and negative likelihood ratio) and AUC (area under receiver operating characteristic-curve) were summarized with a bivariate model. Subgroup analysis and sensitivity analysis were used to explore the heterogeneity.ResultsData of 7792 tests were retrieved from 11 studies. The overall estimates of ROMA for EOC predicting were: sensitivity (0.89, 95% CI 0.84-0.93), specificity (0.83, 95% CI 0.77-0.88), and AUC (0.93, 95% CI 0.90-0.95). Comparison of EOC predictive value between HE4 and CA125 found, specificity: HE4 (0.93, 95% CI 0.87-0.96) > CA125 (0.84, 95% CI 0.76-0.90); AUC: CA125 (0.88, 95% CI 0.85-0.91) > HE4 (0.82, 95% CI 0.78-0.85). Comparison of OC predictive value between HE4 and CA125 found, AUC: CA125 (0.89, 95% CI 0.85-0.91) > HE4 (0.79, 95% CI 0.76-0.83). Comparison among the three tests for EOC prediction found, sensitivity: ROMA (0.86, 95%CI 0.81-0.91) > HE4 (0.80, 95% CI 0.73-0.85); specificity: HE4 (0.94, 95% CI 0.90-0.96) > ROMA (0.84, 95% CI 0.79-0.88) > CA125 (0.78, 95%CI 0.73-0.83).ConclusionsROMA is helpful for distinguishing epithelial ovarian cancer from benign pelvic mass. HE4 is not better than CA125 either for EOC or OC prediction. ROMA is promising predictors of epithelial ovarian cancer to replace CA125, but its utilization requires further exploration.

Dataset Information

Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass.

Publications

Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass.

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