Copenhagen Index versus ROMA in preoperative ovarian malignancy risk stratification: Result from the first Vietnamese prospective cohort study

Tran, Doan Tu; Vo, Van Khoa; Lê, Minh Tâm; Chuang, Linus; Nguyen, Quoc Huy Vu

doi:10.1016/j.ygyno.2021.05.001

Cited by 9 publications

(10 citation statements)

References 21 publications

(29 reference statements)

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“…In their multi-center study, the authors reported that CPH-I showed similar specificity as the established ROMA ® and RMI indices when sensitivity was fixed at 95% (67.3%, 70.7% and 69.5%, respectively). The preoperative performance of CPH-I in comparison to ROMA ® and CA125 alone was further evaluated in several independent studies around the world with similar findings [ 73 , 76 , 77 , 79 , 186 ]. The most recent validation study of the Copenhagen Index illustrated that CPH-I (AUC 0.92; 95% CI: 0.85–0.98) was able to outperform a modified ROMA ® index (AUC 0.54; 95% CI: 0.38–0.69), but was also comparable to a biomarker panel of six serum proteins (AUC 0.90; 95% CI: 0.82–0.97) [ 70 ].…”

Section: Preoperative Diagnosticsmentioning

confidence: 89%

Current and Emerging Methods for Ovarian Cancer Screening and Diagnostics: A Comprehensive Review

Liberto

Chen

Shih

et al. 2022

Cancers

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With a 5-year survival rate of less than 50%, ovarian high-grade serous carcinoma (HGSC) is one of the most highly aggressive gynecological malignancies affecting women today. The high mortality rate of HGSC is largely attributable to delays in diagnosis, as most patients remain undiagnosed until the late stages of -disease. There are currently no recommended screening tests for ovarian cancer and there thus remains an urgent need for new diagnostic methods, particularly those that can detect the disease at early stages when clinical intervention remains effective. While diagnostics for ovarian cancer share many of the same technical hurdles as for other cancer types, the low prevalence of the disease in the general population, coupled with a notable lack of sensitive and specific biomarkers, have made the development of a clinically useful screening strategy particularly challenging. Here, we present a detailed review of the overall landscape of ovarian cancer diagnostics, with emphasis on emerging methods that employ novel protein, genetic, epigenetic and imaging-based biomarkers and/or advanced diagnostic technologies for the noninvasive detection of HGSC, particularly in women at high risk due to germline mutations such as BRCA1/2. Lastly, we discuss the translational potential of these approaches for achieving a clinically implementable solution for screening and diagnostics of early-stage ovarian cancer as a means of ultimately improving patient outcomes in both the general and high-risk populations.

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Section: Preoperative Diagnosticsmentioning

confidence: 89%

Current and Emerging Methods for Ovarian Cancer Screening and Diagnostics: A Comprehensive Review

Liberto

Chen

Shih

et al. 2022

Cancers

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“…Similarly, Tu Tran et al recently reported a sensitivity and specificity of 74.2% and 91.8% for ROMA (cutoff 16.5) and 87.1% and 78.5% for CPH-I (cutoff 1.89), respectively. The authors of the latter work did not find significant differences between the diagnostic performance of ROMA and CPH-I [ 23 ].…”

Section: Discussionmentioning

confidence: 99%

“…A recent meta-analysis retrieving data from 32 studies showed higher AUC and specificity of HE4 in premenopausal women, compared to CA125 and ROMA [ 33 ]. Other authors report higher AUCs for CPH-I, when compared to ROMA and HE4 in premenopausal women [ 23 ].…”

Section: Discussionmentioning

confidence: 99%

“…Several studies evaluating the role of HE4, CA125, and ROMA in preoperative assessment of adnexal masses have been published [ 14 , 16 , 19 , 20 , 21 ]. However, scarce literature regarding the performance of CPH-I can be found [ 18 , 22 , 23 ]. Furthermore, there is little information about the role of ROMA and CPH-I in the evaluation of specific subgroups of patients in which the differential diagnosis of adnexal tumors is particularly challenging, such as women harboring adnexal masses with an inconclusive diagnosis by ultrasonographic examination, women with Stage I EOC (whose diagnosis is difficult by ultrasound [ 24 ], or premenopausal women, in which tumor markers have shown worse performance compared to postmenopausal women [ 19 ]).…”

Section: Introductionmentioning

confidence: 99%

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Comparison of HE4, CA125, ROMA and CPH-I for Preoperative Assessment of Adnexal Tumors

Carreras-Dieguez

Glickman²,

Munmany³

et al. 2022

Diagnostics

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(1) OBJECTIVE: To assess the performance of CA125, HE4, ROMA index and CPH-I index to preoperatively identify epithelial ovarian cancer (EOC) or metastatic cancer in the ovary (MCO). (2) METHODS: single center retrospective study, including women with a diagnosis of adnexal mass. We obtained the AUC, sensitivity, specificity and predictive values were of HE4, CA125, ROMA and CPH-I for the diagnosis of EOC and MCO. Subgroup analysis for women harboring adnexal masses with inconclusive diagnosis of malignancy by ultrasound features and Stage I EOC was performed. (3) RESULTS: 1071 patients were included, 852 (79.6%) presented benign/borderline tumors and 219 (20.4%) presented EOC/MCO. AUC for HE4 was higher than for CA125 (0.91 vs. 0.87). No differences were seen between AUC of ROMA and CPH-I, but they were both higher than HE4 AUC. None of the tumor markers alone achieved a sensitivity of 90%; HE4 was highly specific (93.5%). ROMA showed a sensitivity and specificity of 91.1% and 84.6% respectively, while CPH-I showed a sensitivity of 91.1% with 79.2% specificity. For patients with inconclusive diagnosis of malignancy by ultrasound features and with Stage I EOC, ROMA showed the best diagnostic performance (4) CONCLUSIONS: ROMA and CPH-I perform better than tumor markers alone to identify patients harboring EOC or MCO. They can be helpful to assess the risk of malignancy of adnexal masses, especially in cases where ultrasonographic diagnosis is challenging (stage I EOC, inconclusive diagnosis of malignancy by ultrasound features).

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“…ROMA, OVA1 and OVERA have been cleared by the US Food and Drug Administration (FDA) for diagnosing suspicious adnexal mass, but not for screening [ 19 , 23 ]. A promising modification of ROMA is the Copenhagen Index (CPH-I), calculated from CA125, HE4 and patient age, which seems to be equal or superior to ROMA, and does not require knowledge of the patient’s menopausal status [ 24 , 25 , 26 , 27 ].…”

Section: Introductionmentioning

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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Copenhagen Index versus ROMA in preoperative ovarian malignancy risk stratification: Result from the first Vietnamese prospective cohort study

Abstract: Copenhagen Index (CPH-I) can help stratify the risk of ovarian tumor malignancy.• CPH-I is similarly accurate to but simpler than ROMA.• CPH-I could replace ROMA in clinical practice.

Cited by 9 publications

References 21 publications

Current and Emerging Methods for Ovarian Cancer Screening and Diagnostics: A Comprehensive Review

Current and Emerging Methods for Ovarian Cancer Screening and Diagnostics: A Comprehensive Review

Comparison of HE4, CA125, ROMA and CPH-I for Preoperative Assessment of Adnexal Tumors

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

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