Clinical Performance Comparison of Two In-Vitro Diagnostic Multivariate Index Assays (IVDMIAs) for Presurgical Assessment for Ovarian Cancer Risk

Shulman, L.P.; Francis, Marra; Bullock, Rowan; Pappas, Todd C.

doi:10.1007/s12325-019-01010-8

Cited by 10 publications

(8 citation statements)

References 10 publications

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“…= 78.9% vs. 65.5%; Sens. = 79.2% vs. 91%, respectively) [ 86 ]. However, prospective studies looking at the clinical benefit of the ROMA ® assay for OC diagnosis show conflicting evidence, suggesting that the ROMA ® algorithm provides no advantage to patients over CA125 or HE4 makers alone [ 178 , 179 ].…”

Section: Preoperative Diagnosticsmentioning

confidence: 99%

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: 99%

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

Liberto

Chen

Shih

et al. 2022

Cancers

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“…In their registration trials, both the ROMA and OVERA predicted women likely to have a malignant pelvic mass with 91-94% sensitivity, 69-74% specificity and 97-99% negative predictive value. In a recent direct comparison, OVERA detected more cancers than ROMA, 35 but would also have prompted substantially more referrals of patients with benign disease to gynecologic oncologists. While additional trials will be required to confirm these differences, the greatest need is to use either test more consistently to enhance referral of appropriate patients to the best qualified surgeons.…”

Section: Improving the Initial Stage Of Screeningmentioning

confidence: 99%

Biomarkers and Strategies for Early Detection of Ovarian Cancer

Bast

Lü

Han

et al. 2020

Cancer Epidemiology, Biomarkers &Amp; Prevention

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Early detection of ovarian cancer remains an important unmet medical need. Effective screening could reduce mortality by 10-30%. Used individually, neither serum CA125 nor transvaginal sonography (TVS) is sufficiently sensitive or specific. Two stage strategies have proven more effective, where a significant rise above a woman's baseline CA125 prompts TVS and an abnormal sonogram prompts surgery. Two major screening trials have documented that this strategy has adequate specificity, but sensitivity for early stage (I-II) disease must improve to have a greater impact on mortality. To improve the first stage, different panels of protein biomarkers have detected cases missed by CA125. Autoantibodies against TP53 have detected 20% of early stage ovarian cancers 8 months prior to elevation of CA125 and 22 months prior to clinical diagnosis. Panels of autoantibodies and antigen-autoantibody complexes are being evaluated with the goal of detecting >90% of early stage ovarian cancers, alone or in combination with CA125, while maintaining 98% specificity in control subjects. Other biomarkers, including micro-RNAs, ctDNA, methylated DNA, and combinations of ctDNA alterations are being tested to provide an optimal first stage test. New technologies are also being developed with greater sensitivity than TVS to image small volumes of tumor.

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“…The OVERA test constituted the above, as well as other Pas, including transferrin, apolipoprotein A1, and follicle-stimulating hormone. Both ROMA and OVERA improved first stage sensitivity, while maintaining comparable specificity to ROCA [ 15 ]. They were supported by the Early Detection Research Network (EDRN) and gained United States Food and Drug Administration (FDA) approval in 2011.…”

Section: Introductionmentioning

confidence: 99%

Applications of Proteomics in Ovarian Cancer: Dawn of a New Era

et al. 2022

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The ability to identify ovarian cancer (OC) at its earliest stages remains a challenge. The patients present an advanced stage at diagnosis. This heterogeneous disease has distinguishable etiology and molecular biology. Next-generation sequencing changed clinical diagnostic testing, allowing assessment of multiple genes, simultaneously, in a faster and cheaper manner than sequential single gene analysis. Technologies of proteomics, such as mass spectrometry (MS) and protein array analysis, have advanced the dissection of the underlying molecular signaling events and the proteomic characterization of OC. Proteomics analysis of OC, as well as their adaptive responses to therapy, can uncover new therapeutic choices, which can reduce the emergence of drug resistance and potentially improve patient outcomes. There is an urgent need to better understand how the genomic and epigenomic heterogeneity intrinsic to OC is reflected at the protein level, and how this information could potentially lead to prolonged survival.

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Clinical Performance Comparison of Two In-Vitro Diagnostic Multivariate Index Assays (IVDMIAs) for Presurgical Assessment for Ovarian Cancer Risk

Cited by 10 publications

References 10 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

Biomarkers and Strategies for Early Detection of Ovarian Cancer

Applications of Proteomics in Ovarian Cancer: Dawn of a New Era

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