Diagnostic Added-Value of Serum CA-125 on the IOTA Simple Rules and Derivation of Practical Combined Prediction Models (IOTA SR X CA-125)

Phinyo, Phichayut; Patumanond, Jayanton; Saenrungmuaeng, Panprapha; Chirdchim, Watcharin; Pipanmekaporn, Tanyong; Tantraworasin, Apichat; Tongsong, Theera; Tantipalakorn, Charuwan

doi:10.3390/diagnostics11020173

Cited by 11 publications

(9 citation statements)

References 36 publications

(58 reference statements)

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“…Ultrasonography, especially vaginal ultrasonography, is currently the first choice for diagnosing gynecological diseases, 11 and it can clearly show the internal structure of a lesion and its anatomical relationship with the peripheral tissues. However, the accuracy of diagnosis varies greatly based on the experience of the sonographer.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Diagnostic Value of the Ultrasound ADNEX Model for Benign and Malignant Ovarian Tumors

Peng

Wang

et al. 2021

IJGM

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To investigate the diagnostic performance of the ADNEX model in the International Ovarian Tumor Analysis diagnostic models for ovarian tumors and further explore its application value in the staging of ovarian tumors. Methods: A total of 224 patients who underwent ultrasound for evaluation of adnexal masses and were treated surgically owing to adnexal masses from January 2018 to June 2020 in our hospital were selected for research on the diagnostic accuracy of the ADNEX model. The clinical information and ultrasonographic findings of the patients were collected, and the pathological diagnosis was taken as the gold standard. According to the ADNEX model, the ovarian tumors were divided into five subtypes: benign and borderline, stage I, stage II-IV, and metastatic cancer. The sensitivity, specificity, positive predictive value, negative predictive value, diagnostic odds ratio, and area under the receiver operating characteristics curve (AUC) of the ADNEX model were calculated. Results: Of the 224 patients, 119 (53.1%) developed benign tumors and 105 (46.9%) had malignant tumors. When the cut-off value for malignancy risk was 10%, the ADNEX model including CA 125 achieved a sensitivity of 94.3% (95% CI: 88.0-97.9%), specificity of 74.0% (95% CI: 65.1-81.6%), positive predictive value of 76.2% (95% CI: 70.2-81.3%), negative predictive value of 93.6% (95% CI: 87.0-97.0%), diagnostic odds ratio of 45.25, and an AUC of 0.94 (95% CI: 0.90-0.97) for differentiating between benign and malignant ovarian tumors. The AUC in the model excluding CA 125 was 0.93 (95% CI: 0.89-0.96), but the difference was not statistically significant (P=0.20). The accuracy of the ADNEX model for the diagnosis of ovarian tumors of all subtypes exceeds 80% when CA 125 measurements were included in the application, but the sensitivity for diagnosing borderline, stage I, and metastatic ovarian tumors was only 60.0% (95% CI:36.1-80.9%), 28.6% (95% CI:8.4-58.1%) and 45.5% (95% CI:16.7-76.6%). Conclusion:The ADNEX model shows good diagnostic performance in differentiating between benign and malignant ovarian tumors. The model has a certain clinical value in the diagnosis of all subtypes of ovarian tumors, but the sensitivity is unsatisfactory for the diagnosis of borderline, stage I, and metastatic ovarian tumors and needs to be verified.

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Section: Discussionmentioning

confidence: 99%

Evaluation of the Diagnostic Value of the Ultrasound ADNEX Model for Benign and Malignant Ovarian Tumors

Peng

Wang

et al. 2021

IJGM

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“…Besides, other imaging or ultrasound models have been proposed to address these masses, such as MRI, contrast-enhanced ultrasound (CEUS), the Risk of Malignancy Index (RMI), the Risk of Malignancy Algorithm (ROMA), the Assessment of Different NEoplasias in the adneXa (ADNEX) model [27][28][29][30] . A previous study [31] also exploited a logistic regression model based on SR and CA125 and validated the value. While all methods the above solved the problem of inconclusive masses and improved the diagnostic e ciency to a certain extent, it was not easy to execute.…”

Section: Discussionmentioning

confidence: 98%

Diagnostic added-value of CA125 on O-RADS and Simple Rules in discrimination benign and malignant adnexal masses

Gong

Dong

et al. 2022

Preprint

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Objective: Since the promulgation of the International Ovarian Tumor Analysis (IOTA) Simple Rules (SR) and the American College of Radiology (ACR) Ovarian-Adnexal Reporting and Data System (O-RADS) , many studies have verified their diagnostic performance successively. But the low accuracy of masses of O-RADS 4 and SR inconclusive still perplex sonographers, thus this study aimed to settle this problem by combining Cancer Antigen 125 (CA125) with those masses, and to assess diagnostic added-value of CA125 on O-RADS and SR in discrimination benign and malignant adnexal masses. Methods: Data of women with adnexal masses recruited from a tertiary center between January 2019 and September 2021 were included in this study. All patients underwent transvaginal or transabdominal ultrasound examination as well as had complete ultrasound images and clinical data. Firstly, the masses were classified retrospectively using O-RADS and SR by two less experienced sonographers according to the corresponding criteria. Then, the masses of O-RADS 4 and SR inconclusive were reclassified according to the level of CA125,that is, the combination of O-RADS and SR with CA125. And analyzed the differences in diagnostic efficacy of the above methods for menopause status. Finally, receiver operating characteristic (ROC) curves were plotted to evaluate the diagnostic performance of CA125,O-RADS, SR, CA125 combine with O-RADS, and CA125 combine with SR, and calculate the area under the curve (AUC), sensitivity, specificity. Results: Of the 403 patients (143 premenopausal and 260 postmenopausal), 269 had benign lesions, and 134 had malignant tumors. The AUCs of CA125, O-RADS, SR, O-RADS combined with CA125, SR, SR combined with CA125,and CA125 in the whole study group were 0.842, 0.939, 0.963, 0.884, and 0.944, respectively. The findings showed that the AUCs of O-RADS and SR combined with CA125 were significantly higher than O-RADS and SR alone severally (p <0.05). The accuracy of O-RADS 4 and SR inconclusive masses were only 0.438 and 0.534, however, their accuracy has been improved to 0.829 and 0.814 when combined with CA125. Furthermore, the addition of CA125 into O-RADS and SR significantly increased the AUC to 0.930 (0.930 vs 0.712, p <0.001) and 0.931 (0.931 vs 0.774, p <0.001) separately in women with amenorrhea. Conclusions: CA125 can markedly improve the accuracy of O-RADS 4 and SR inconclusive masses, thereby improving the overall diagnostic efficiency of the O-RADS and SR classification system, especially for menopause women.

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“…We hypothesize that diagnostic models created by adding biomarkers of tumor antigen type offer increased but still limited accuracy and, therefore, combining different categories of biomarkers, e.g., CA125 with inflammatory markers, antibodies and age would be the right way to discover maximally effective tools for OC diagnosis. Future studies could evaluate the utility of combining our diagnostic models with sonographic criteria [ 64 ] or body mass index [ 65 ].…”

Section: Discussionmentioning

confidence: 99%

Biomarker-Based Models for Preoperative Assessment of Adnexal Mass: A Multicenter Validation Study

Watrowski

Obermayr

Wallisch

et al. 2022

Cancers

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Ovarian cancer (OC) is the most lethal genital malignancy in women. We aimed to develop and validate new proteomic-based models for non-invasive diagnosis of OC. We also compared them to the modified Risk of Ovarian Malignancy Algorithm (ROMA-50), the Copenhagen Index (CPH-I) and our earlier Proteomic Model 2017. Biomarkers were assessed using bead-based multiplex technology (Luminex®) in 356 women (250 with malignant and 106 with benign ovarian tumors) from five European centers. The training cohort included 279 women from three centers, and the validation cohort 77 women from two other centers. Of six previously studied serum proteins (CA125, HE4, osteopontin [OPN], prolactin, leptin, and macrophage migration inhibitory factor [MIF]), four contributed significantly to the Proteomic Model 2021 (CA125, OPN, prolactin, MIF), while leptin and HE4 were omitted by the algorithm. The Proteomic Model 2021 revealed a c-index of 0.98 (95% CI 0.96, 0.99) in the training cohort; however, in the validation cohort it only achieved a c-index of 0.82 (95% CI 0.72, 0.91). Adding patient age to the Proteomic Model 2021 constituted the Combined Model 2021, with a c-index of 0.99 (95% CI 0.97, 1) in the training cohort and a c-index of 0.86 (95% CI 0.78, 0.95) in the validation cohort. The Full Combined Model 2021 (all six proteins with age) yielded a c-index of 0.98 (95% CI 0.97, 0.99) in the training cohort and a c-index of 0.89 (95% CI 0.81, 0.97) in the validation cohort. The validation of our previous Proteomic Model 2017, as well as the ROMA-50 and CPH-I revealed a c-index of 0.9 (95% CI 0.82, 0.97), 0.54 (95% CI 0.38, 0.69) and 0.92 (95% CI 0.85, 0.98), respectively. In postmenopausal women, the three newly developed models all achieved a specificity of 1.00, a positive predictive value (PPV) of 1.00, and a sensitivity of >0.9. Performance in women under 50 years of age (c-index below 0.6) or with normal CA125 (c-index close to 0.5) was poor. CA125 and OPN had the best discriminating power as single markers. In summary, the CPH-I, the two combined 2021 Models, and the Proteomic Model 2017 showed satisfactory diagnostic accuracies, with no clear superiority of either model. Notably, although combining values of only four proteins with age, the Combined Model 2021 performed comparably to the Full Combined Model 2021. The models confirmed their exceptional diagnostic performance in women aged ≥50. All models outperformed the ROMA-50.

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Diagnostic Added-Value of Serum CA-125 on the IOTA Simple Rules and Derivation of Practical Combined Prediction Models (IOTA SR X CA-125)

Cited by 11 publications

References 36 publications

Evaluation of the Diagnostic Value of the Ultrasound ADNEX Model for Benign and Malignant Ovarian Tumors

Evaluation of the Diagnostic Value of the Ultrasound ADNEX Model for Benign and Malignant Ovarian Tumors

Diagnostic added-value of CA125 on O-RADS and Simple Rules in discrimination benign and malignant adnexal masses

Biomarker-Based Models for Preoperative Assessment of Adnexal Mass: A Multicenter Validation Study

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