Adnexal Mass Risk Assessment: A Multivariate Index Assay for Malignancy Risk Stratification

Zhang, Zhen; Bullock, Rowan

doi:10.2217/fon-2019-0479

Cited by 6 publications

(3 citation statements)

References 10 publications

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“…Of note, the predictive values were quite balanced due to the disease prevalence that was 51.5% (123/239) in the first cohort and 57.1% (20/35) in the second independent cohort. This balanced prevalence, as expected [ 31 ], enhances the role of the DSS in predicting the risk of malignancy allowing to strongly reduce both false positives and false negatives. We would also specify that all patients enrolled in the study underwent surgery for various reasons: suspicion of malignancy on ultrasound, patient request, symptoms worsening the quality of life, reasons connected with fertility.…”

Section: Discussionsupporting

confidence: 62%

A decision support system based on radiomics and machine learning to predict the risk of malignancy of ovarian masses from transvaginal ultrasonography and serum CA-125

Chiappa

Interlenghi²,

Bogani

et al. 2021

Eur Radiol Exp

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Background To evaluate the performance of a decision support system (DSS) based on radiomics and machine learning in predicting the risk of malignancy of ovarian masses (OMs) from transvaginal ultrasonography (TUS) and serum CA-125. Methods A total of 274 consecutive patients who underwent TUS (by different examiners and with different ultrasound machines) and surgery, with suspicious OMs and known CA-125 serum level were used to train and test a DSS. The DSS was used to predict the risk of malignancy of these masses (very low versus medium-high risk), based on the US appearance (solid, liquid, or mixed) and radiomic features (morphometry and regional texture features) within the masses, on the shadow presence (yes/no), and on the level of serum CA-125. Reproducibility of results among the examiners, and performance accuracy, sensitivity, specificity, and area under the curve were tested in a real-world clinical setting. Results The DSS showed a mean 88% accuracy, 99% sensitivity, and 77% specificity for the 239 patients used for training, cross-validation, and testing, and a mean 91% accuracy, 100% sensitivity, and 80% specificity for the 35 patients used for independent testing. Conclusions This DSS is a promising tool in women diagnosed with OMs at TUS, allowing to predict the individual risk of malignancy, supporting clinical decision making.

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Section: Discussionsupporting

confidence: 62%

A decision support system based on radiomics and machine learning to predict the risk of malignancy of ovarian masses from transvaginal ultrasonography and serum CA-125

Chiappa

Interlenghi²,

Bogani

et al. 2021

Eur Radiol Exp

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“…The previous site collections were done according to five different protocols, including OVA1-001-CO1, OVA2-002-CO3, OVA1-7788, OVA1-PS1-CO4, and RP 01-2016. The purpose of each collection has previously been reported [6][7][8][9]. Each site independently obtained Institutional Review Board approval.…”

Section: Methodsmentioning

confidence: 99%

Salvaging Detection of Early-Stage Ovarian Malignancies When CA125 Is Not Informative

Dunton

Hutchcraft

Bullock³

et al. 2021

Diagnostics

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Background: Ovarian cancer is the deadliest gynecologic cancer, with no recommended screening test to assist with early detection. Cancer antigen 125 (CA125) is a serum biomarker commonly used by clinicians to assess preoperative cancer risk, but it underperforms in premenopausal women, early-stage malignancies, and several histologic subtypes. OVA1 is a multivariate index assay that combines CA125 and four other serum proteins to assess the malignant risk of an adnexal mass. Objective: To evaluate the performance of OVA1 in a cohort of patients with low-risk serum CA125 values. Study Design: We analyzed patient data from previous collections (N = 2305, prevalence = 4.5%) where CA125 levels were at or below 67 units/milliliter (U/mL) for pre-menopausal women and 35 U/mL for post-menopausal women. We compare the performance of OVA1 to CA125 in classifying the risk of malignancy in this cohort, including sensitivity, specificity, positive and negative predictive values. Results: The overall sensitivity of OVA1 in patients with a low-risk serum CA125 was 59% with a false-positive rate of 30%. OVA1 detected over 50% of ovarian malignancies in premenopausal women despite a low-risk serum CA125. OVA1 also correctly identified 63% of early-stage cancers missed by CA125. The most common epithelial ovarian cancer subtypes in the study population were mucinous (25%) and serous (23%) carcinomas. Despite a low-risk CA125, OVA1 successfully detected 83% of serous, 58% of mucinous, and 50% of clear cell ovarian cancers. Conclusions: As a standalone test, CA125 misses a significant number of ovarian malignancies that can be detected by OVA1. This is particularly important for premenopausal women and early-stage cancers, which have a much better long-term survival than late-stage malignancies. Using OVA1 in the setting of a normal serum CA125 can help identify at-risk ovarian tumors for referral to a gynecologic oncologist, potentially improving overall survival.

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“…Ovarian cancer is the fifth highest cause of cancer related deaths among women [ 1 , 2 ]. An estimated 5–10% of women will develop an adnexal mass during their lifetime [ 3 ]. Surgical intervention is a common treatment option, yet studies have shown that only 10% of the 200,000 patients in the USA who undergo surgery for an adnexal mass annually are found to have ovarian cancer [ 4 ].…”

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confidence: 99%

A real-world comparison of the clinical and economic utility of OVA1 and CA125 in assessing ovarian tumor malignancy risk

et al. 2023

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Aim: This largest-of-its-kind study evaluated the clinical utility of CA125 and OVA1, commonly used as ovarian tumor markers for assessing the risk of malignancy. The research focused on the ability and utility of these tests to reliably predict patients at low risk for ovarian cancer. Clinical utility endpoints were 12-month maintenance of benign mass status, reduction in gynecologic oncologist referral, avoidable surgical intervention and associated cost savings. Materials & methods: This was a multicenter retrospective review of data from electronic medical records and administrative claims databases. Patients receiving a CA125 or OVA1 test between October 2018 and September 2020 were identified and followed for 12 months using site-specific electronic medical records to assess tumor status and utilization outcomes. Propensity score adjustment was used to control for confounding variables. Payer allowed amounts from Merative MarketScan Research Databases were used to estimate 12-month episode-of-care costs per patient, including surgery and other interventions. Results: Among 290 low-risk OVA1 patients, 99.0% remained benign for 12 months compared with 97.2% of 181 low-risk CA125 patients. The OVA1 cohort exhibited 75% lower odds of surgical intervention in the overall sample of patients (Adjusted OR: 0.251, p ≤ 0.0001), and 63% lower odds of gynecologic oncologist utilization among premenopausal women (Adjusted OR: 0.37, p = 0.0390) versus CA125. OVA1 demonstrated significant savings in surgical interventions ($2486, p ≤ 0.0001) and total episode-of-care costs ($2621, p ≤ 0.0001) versus CA125. Conclusion: This study underscores the utility of a reliably predictive multivariate assay for assessing ovarian cancer risk. For patients assessed at low risk of ovarian tumor malignancy, OVA1 is associated with a significant reduction in avoidable surgeries and substantial cost savings per patient. OVA1 is also associated with a significant reduction in subspecialty referrals for low-risk premenopausal patients.

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Adnexal Mass Risk Assessment: A Multivariate Index Assay for Malignancy Risk Stratification

Cited by 6 publications

References 10 publications

A decision support system based on radiomics and machine learning to predict the risk of malignancy of ovarian masses from transvaginal ultrasonography and serum CA-125

A decision support system based on radiomics and machine learning to predict the risk of malignancy of ovarian masses from transvaginal ultrasonography and serum CA-125

Salvaging Detection of Early-Stage Ovarian Malignancies When CA125 Is Not Informative

A real-world comparison of the clinical and economic utility of OVA1 and CA125 in assessing ovarian tumor malignancy risk

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