Risk Of Ovarian Malignancy Algorithm Score Research Articles

A label-free dual immunosensor for the simultaneous electrochemical determination of CA125 and HE4 biomarkers for the early diagnosis of ovarian cancer.

The blood levels of cancer antigen 125 (CA125) and human epididymal secretory protein 4 (HE4) are measured in the diagnosis and progression monitoring of ovarian cancer (OC), and the Risk of Ovarian Malignancy Algorithm (ROMA) score% values are calculated for cancer risk assessment. For the first time, disposable dual screen-printed carbon electrodes modified with reduced graphene oxide, polythionine, and gold nanoparticles were used to fabricate label-free electrochemical dual CA125-HE4 immunosensors for the sensitive, fast, and practical simultaneous determination of CA125 and HE4. DPV and SWV methods were used to simultaneously determine antigens in two different linear ranges (1-100pgmL-1 and 1-50ngmL-1). High sensitivity, low LOD, and LOQ were obtained for two linear ranges with a correlation coefficient above 0.99. The application stability of the dual CA125-HE4 immunosensors was determined as 60days, and the storage stability was determined as 16weeks. The dual immunosensors exhibited high selectivity in eight different antigen mixtures. The reusability of the dual immunosensors has been tested up to 9 cycles. ROMA score% values for pre-menopausal and post-menopausal status were calculated using the concentration of CA125 and HE4 in the blood serum and assessing OC risk. The disposable dual immunosensors can be used in point-of-care tests for rapid and practical simultaneous determination of CA125 and HE4 with high selectivity, sensitivity, and repeatability.

Cost-analysis comparison of clinical risk assessment with and without ROMA for the management of women with pelvic masses

Objective: Pelvic masses can be classified as low risk (likely benign) and high risk (likely malignant) based on an initial clinical risk assessment, which involves a detailed history, physical exam, basic laboratory tests, and imaging. In recent years, the Risk of Ovarian Malignancy Algorithm (ROMA), which combines CA125, HE4 and menopausal status, has emerged as a powerful tool in the classification of pelvic masses and triage of patients to either a generalist gynecologist or a gynecologic oncologist for management. The objective of this study was to evaluate whether the use of ROMA, alone or in combination with Initial Clinical Risk Assessment (ICRA), provides cost savings compared to triage based on ICRA alone. Methods: A health-economic decision model was developed to assess clinical and cost differences associated with three different clinical pathways of risk assessment for a pelvic mass: ICRA alone, ROMA alone, or ICRA + ROMA in combination. Using previously reported accuracy rates and patient characteristics from a prospective, multicenter, blinded clinical trial, total healthcare costs were modeled for each clinical pathway using the Medicare 2020 reimbursement rates. Results: A total of 461 patients with pelvic masses were included with 10.4% ultimately diagnosed with epithelial ovarian cancer. Total healthcare costs for patients with benign disease, EOC, or low malignant potential tumors (LMP) (n = 441) triaged using ROMA alone were 3.3% lower than when triaged using ICRA alone. While lab costs increased 55% using ROMA, the use of ROMA alone resulted in a 4% decrease in laparoscopy costs and a 3.1% decrease in laparotomy costs compared with ICRA alone. Similarly, total costs associated with a combination of ICRA + ROMA were 3.9% lower than total costs associated with ICRA alone. The model also predicted a 63% reduction in repeat surgeries resulting from false negative ICRA when using ROMA to triage patients. Conclusion: Triage of women with pelvic masses using the more sensitive ROMA score lowers overall healthcare costs compared to ICRA alone. With fewer false negative results than ICRA alone, the ROMA score improves initial detection of malignancy and reduces second surgical treatments in women with pelvic masses.

A Study to Evaluate Risk of Ovarian Malignancy Algorithm (ROMA) in Patients with Ovarian Masses

Abstract Objective The aim of this study was to evaluate risk of ovarian malignancy algorithm (ROMA) in premenopausal patients with ovarian masses. Materials and Methods A mixed observational study was conducted in the Department of Obstetrics and Gynecology at Lilavati Hospital and Research Centre, Mumbai, from the month of June 2017 to March 2018. In this study, premenopausal females with ovarian masses, satisfying the inclusion criteria, were evaluated for the purpose of preoperative analysis. Results In premenopausal females, ROMA less than 11.4% is normal and more than or equal to 1.4% is increased. Considering histopathology reports as the gold standard, significant association was present between ROMA score and premenopausal status. Conclusion ROMA includes two recognized markers that are being used in the current scenario for the purpose of preoperative risk assessment of ovarian cancer, cancer antigen 125 (CA125), and human epididymis protein 4 (HE4). CA125 has been shown to be elevated in most ovarian cancer cells but has a low specificity for ovarian malignancies. HE4 is a recently developed biomarker that is elevated in ovarian cancers, as well as few other cancers, and has been shown to have higher specificity than CA125. Combining CA125 and HE4 provides a relatively more accurate prediction of malignancy than either test alone. ROMA culminates the benefits of the combined CA125 and HE4 biomarkers along with menopausal status to help assign a numeric risk stratification of malignancy in cases of ovarian tumors.

Characterization and comparison of pelvic mass risk assessment by gynecologists and PCPs to ROMA

<h3>Objectives:</h3> Pelvic masses can be classified as low risk (likely benign) and high risk (likely malignant) based on an initial clinical risk assessment (ICRA). The clinical assessment impacts the management and referral plan that patients receive. The objective of this study was to compare the ICRA and referral performances of primary care physicians (PCPs) and generalist gynecologists (GYNs) in the evaluation of a pelvic mass to the risk of ovarian malignancy algorithm (ROMA). <h3>Methods:</h3> Results from a prospective, multicenter trial (ClinicalTrial. gov identifier NCT00987649), evaluating women with a pelvic mass that had an ICRA performed by a non-gynecologic oncologist were used for this study. ICRA included history, physical exam, any combination of imaging (ultrasound, CT scan, MRI) and CA125 all at the physician's discretion. Types of imaging utilized in evaluation and ROMA scores were determined, and statistical parameters were calculated for the ability of ICRA and ROMA to differentiate between benign and malignant masses. <h3>Results:</h3> A total of 398 patients were included in the analysis (229 premenopausal, 169 postmenopausal), with 332 being evaluated by GYNs and 66 by PCPs. A total of 40 patients (10.1%) were diagnosed with epithelial ovarian cancer (EOC). False negative assessments for EOC comprised 5.7% and 1.4% of the subjects with a benign ICRA as determined by PCPs versus GYNs respectively (p=0.138). PCPs ICRA achieved a sensitivity of 88.2% and specificity of 67.3% compared with GYNs ICRA with a sensitivity of 82.6% and a specificity of 88.3%. The IRCA accuracy for PCPs was 72.7% versus an accuracy of 88.0% for GYNs (p=0.003). In premenopausal women the PCP ICRA achieved a sensitivity of 50.0% with a specificity of 68.2%. The GYNs ICRA sensitivity was 40.0% with a specificity of 93.0%. The accuracy for PCPs was 66.7% compared with 91.7% for GYNs (p<0.001). In postmenopausal women the PCPs ICRA achieved a sensitivity of 93.3% with a specificity of 66.7%. The GYNs ICRA sensitivity was 94.4% with a specificity of 79.8%. The accuracy for PCPs was 76.2% compared with 81.9% for GYNs (p=0.501). PCPs were approximately 2.2x more likely to include CT scans in their initial evaluation (60.6% vs. 27.5%) and were less likely to include ultrasound (56.1% vs 84.6%), which overall is a more cost intensive approach. In the 398 patients, the ROMA score achieved a sensitivity of 95.0% with a specificity of 75.4%. Use of the ROMA score alone for triage would have resulted in 4 more patients with EOC being directly referred to a gynecologic oncologist that were not referred through ICRA alone. <h3>Conclusions:</h3> GYNs more accurately use ICRA to stratify pelvic masses into benign and malignant categories, particularly in premenopausal women, and they tend to take a more cost-effective approach to initial risk assessment compared to PCPs. Use of the ROMA identifies additional EOC cases not identified by ICRA.

Cost-analysis comparison of initial clinical risk assessment and ROMA score for the triage of women with pelvic masses

<h3>Objectives:</h3> In recent years, the Risk of Ovarian Malignancy Algorithm (ROMA) score has emerged as a useful tool in the triage of women with pelvic masses. Previously, triage of women with pelvic masses to management by either benign gynecology or gynecologic oncology was performed with an initial clinical risk assessment (ICRA) alone, involving a detailed history, exam, basic laboratory tests, and imaging. We sought to determine whether use of ROMA, which is calculated using CA125, HE4, and menopausal status for triage of women with pelvic masses, provides cost savings compared to triage based on ICRA alone. <h3>Methods:</h3> A health-economic decision model was developed to assess clinical and cost differences associated with referrals for patients presenting to their gynecologist or primary care physician with an adnexal mass. In our study, we modeled the differences of two clinical pathways that included 1) use of ICRA alone and 2) use of ROMA as a determining factor in referral to a gynecologic oncologist. Using previously reported accuracy rates and patient characteristics from a prospective, multicenter, blinded clinical trial (ClinicalTrial. gov identifier NCT00987649), we assessed triage of women with a pelvic mass using ICRA alone or ROMA and modeled the related lab testing, imaging, surgical procedures, and associated costs. Costs were estimated using current Medicare reimbursement rates. <h3>Results:</h3> A total of 423 patients with pelvic masses were included. Total healthcare costs for patients triaged for epithelial ovarian cancer (EOC) using ICRA alone were higher than when triaged by ROMA ($2,461,301 vs $2,428,628), a cost savings of 1.3%. While lab costs increased 55% when using ROMA ($16,006 vs $24,809), all other costs decreased, including total laparoscopy ($1,931,568 vs $1,896,314, -1.8% difference), total laparotomy ($436,910 vs $430,689, -1.4% difference), and total surgery ($2,368,479 vs $2,327,003, -1.8% difference) (Table 1). Repeat surgeries resulting from false negative ICRA were also reduced when using ROMA (8 vs 3), a 64% decrease. Notably, total healthcare costs were further reduced when including patients with low malignant potential (LMP) tumors ($2,646,738 vs $2,558,834, -3.3% difference) and analysis of all cancers ($2,847,829 vs $2,728,247, -4.2% difference). A similar reduction in repeat surgeries was noted in patients with LMP tumors (19 for ICRA, 7 for ROMA, -61% difference) and in all cancers (29 for ICRA, 14 for ROMA, -53% difference). <h3>Conclusions:</h3> Triage of women with a pelvic mass using the more sensitive ROMA score compared to ICRA alone lowers overall healthcare costs. With fewer false negatives than ICRA alone, the ROMA score improves initial detection of malignancy and reduces second surgical treatments in women with pelvic masses.

Diagnostic Performance of F-18 FDG PET/CT Compared with CA125, HE4, and ROMA for Epithelial Ovarian Cancer.

Objective:This study aimed to examine the diagnostic performance of F-18 fluorodeoxyglucose positron emission tomography with computed tomography (F-18 FDG PET/CT) compared with cancer antigen 125 (CA125), human epididymis protein 4 (HE4), and risk of ovarian malignancy algorithm (ROMA) score to distinguish epithelial ovarian cancer from benign tumors. Methods:A total of 46 patients with pelvic masses, who underwent F-18 FDG PET/CT, CA125, and HE4 before surgery between January 2015 and December 2018, were included in this retrospective study. The diagnostic performance of CA125, HE4, ROMA score, and maximum standardized uptake value (SUVmax) to differentiate epithelial ovarian cancer from benign pelvic tumors was examined by receiver operating characteristic curve analysis. Results:Among the 46 patients, 28 were cases of ovarian cancers and 18 were of benign. The mean values of CA125, HE4, ROMA score, and SUVmax were significantly higher in the ovarian cancer group than the benign group. In early cancer stages (stages I and II), Area under the curve for SUVmax was significantly higher than CA125 and ROMA score (0.778 for CA125, 0.753 for HE4, 0.682 for ROMA score, and 0.922 for SUVmax). Conclusion:SUVmax using F-18 FDG PET/CT showed a high diagnostic accuracy for differentiating epithelial ovarian cancer from benign pelvic tumors, including early stage ovarian cancer. F-18 FDG PET/CT can be a useful modality for the assessment of pelvic mass.

Role of HE4 and ROMA Score in Diagnosis of Ovarian Cancer in Egyptian Women

Background: Risk of ovarian malignancy algorithm (ROMA) combining human epididymis secretory protein 4 (HE4) and CA125 is a novel score, specific for epithelial ovarian cancer (EOC). Method: Our cohort prospective study aimed to evaluate the role of HE4 and ROMA score in the diagnosis of EOC. We determined CA125 and HE4 serum levels in 56 premenopausal women with ovarian mass (38 women with benign ovarian mass and 18 women with malignant ovarian mass), 56 postmenopausal women with ovarian mass (20 women with benign ovarian mass and 36 women with malignant ovarian mass), and 56 healthy women as control. Results: Serum CA125 and HE4 and ROMA score were significantly higher among postmenopausal group compared with premenopausal and control groups (P< 0.001), and the median serum CA125 and HE4 and ROMA levels were statistically higher among malignant lesions compared with benign lesions and control group (P< 0.001). The sensitivity and specificity of HE4 and ROMA vs. CA125 in discriminating ovarian cancer from benign ovarian tumor was (88% and 98% vs. 90%) and (97% and 99% vs. 80%), respectively. ROMA had better sensitivity and specificity compared to CA125 and HE4 in premenopausal and postmenopausal women (P <0.001) In premenopausal patients, there was a statistically significant difference regarding the area under the curve (AUC) of ROMA vs. CA125 (P=0.004) and ROMA vs. HE4 (P =0.02). Conclusion: ROMA score showed a better performance in comparison with either CA125 or HE4 alone in premenopausal patients. HE4 and ROMA score significantly differentiated early from late stage ovarian cancer.

Low serum T3 levels are associated with false-positive results when using the risk of ovarian malignancy algorithm (ROMA) in women with benign ovarian disease

ObjectiveWe investigated factors that could cause false-positive results when using the risk of ovarian malignancy algorithm (ROMA) for assessing ovarian cancer risk. Materials and methodsROMA scores were calculated from patients followed surgery to remove a pelvic mass. We compared a false-positive group with a true-negative group of ROMA scores. ResultsWe analyzed 324 patients using medical records. There were 22 with an epithelial ovarian cancer (EOC), 15 with a borderline ovarian tumor, and 287 with benign disease. Twenty-nine (10.1%) of the patients with benign disease showed high-risk ROMA score (false positive) and 13/37 (35%) patients with EOC, or borderline ovarian tumor showed low ROMA scores (false negatives). The median serum triiodothyronine (T3) level of the false-positive ROMA group in patients with benign disease was lower than in the true-negative ROMA group (p < 0.001) and the estimated glomerular filtration rate (eGFR) was also lower (p = 0.001) in the false-positive ROMA group. Median serum T3 levels in the true-positive ROMA group among patients with EOC, or borderline ovarian tumor were lower than in the false-negative ROMA group (p = 0.043). ConclusionMedian serum T3 level and eGFR in the false-positive ROMA group in patients with benign ovarian disease were lower than in the true-negative group.

Perbandingan Akurasi Skor ROMA dan IOTA dalam Prediksi Keganasan Tumor Ovarium

Ovarian cancer is the sixth most common cancer found among women. Incidence of ovarian cancer in Dr. M. Djamil Central Hospital had increased from 103 cases to 156 cases in 2011-2012. The Risk Of Ovarian Malignancy Algorithm (ROMA) consists of qualitative serum test where several variables including HE4 serum, CA125 serum, and menopausal status are turned into numerical score (Hye Yon Cho et al 2015). The latest diagnostic modalities developed by International Ovarian Tumour Analysis (IOTA) classifies tumour into four sub groups, based on ultrasound characteristics: unilocular, multilocular, adnexal mass with solid component without papilloma projection, adnexal mass with one or more papilloma projection. Based on this knowledge, author would like to investigate accuracy of ROMA and IOTA score in predicting malignancy status of early ovarian tumour.Objective: Determining ROMA and IOTA so thus can be utilised to predict wether the ovarian tumour is benign or malignant.Method: This was analytical study, with cross sectional design and took place in Obstetrical and Gynaecological Outpatient Clinic of Dr. M. Djamil Central Hospital from August 2016 to January 2019. Sample was recruited using consecutive sampling method. Sixty one participants were recruited with CI 99%. Patients who met inclusion criteria would undergo Ca125 serum test and IOTA score. HE4 level was determined after surgery and the sample of a tumour was sent to pathology anatomy laboratory of Medical Faculty of Andalas University to investigate the malignancy status. Statistical analysis involved univariate and bivariate test. The variables included frequency distribution, ROMA, and IOTA score. Bivariate analysis included specificity, sensitivity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio.Result: Thirty one patients (50,8%) from peri menopausal group had HE4 level ≤70 pmol/L and 30 patients (49,2%) from post menopause group had HE4 level ≤140 pmol/L. Eleven patients (18%) had CA125 level &lt;35 and 50 patients (82%) had CA125 level ≥35. ROMA index showed low risk in 17 patients (27,9%) and high risk 44 patients (72,1%). IOTA with M Rules was 51 patients (83,6%) and B rules was 10 patients (16,4%). Diagnostic value for ROMA score had sensitivity of 71,9%; RMI of 84,2%; and IOTA 82,5%. ROMA and IOTA accuracy was 68,9% and 92,2%, respectively.Conclusion: IOTA has better sensitivity in predicting ovarian tumour compared with ROMA. ROMA has higher positive predictive value compared with IOTA positive predictive value. ROMA negative predictive value is 5,9%, meanwhile for IOTA it is hard to determineKeywords: ovarian cancer, ROMA, IOTA, Ca-125, HE4

Perbandingan Akurasi Skor ROMA dan IOTA dalam Prediksi Keganasan Tumor Ovarium

Ovarian cancer is the sixth most common cancer found among women. Incidence of ovarian cancer in Dr. M. Djamil Central Hospital had increased from 103 cases to 156 cases in 2011-2012. The Risk Of Ovarian Malignancy Algorithm (ROMA) consists of qualitative serum test where several variables including HE4 serum, CA125 serum, and menopausal status are turned into numerical score (Hye Yon Cho et al 2015). The latest diagnostic modalities developed by International Ovarian Tumour Analysis (IOTA) classifies tumour into four sub groups, based on ultrasound characteristics: unilocular, multilocular, adnexal mass with solid component without papilloma projection, adnexal mass with one or more papilloma projection. Based on this knowledge, author would like to investigate accuracy of ROMA and IOTA score in predicting malignancy status of early ovarian tumour. Objective : Determining ROMA and IOTA so thus can be utilised to predict wether the ovarian tumour is benign or malignant. Method : This was analytical study, with cross sectional design and took place in Obstetrical and Gynaecological Outpatient Clinic of Dr. M. Djamil Central Hospital from August 2016 to January 2019. Sample was recruited using consecutive sampling method. Sixty one participants were recruited with CI 99%. Patients who met inclusion criteria would undergo Ca125 serum test and IOTA score. HE4 level was determined after surgery and the sample of a tumour was sent to pathology anatomy laboratory of Medical Faculty of Andalas University to investigate the malignancy status. Statistical analysis involved univariate and bivariate test. The variables included frequency distribution, ROMA, and IOTA score. Bivariate analysis included specificity, sensitivity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio. Result : Thirty one patients (50,8%) from peri menopausal group had HE4 level ≤70 pmol/L and 30 patients (49,2%) from post menopause group had HE4 level ≤140 pmol/L. Eleven patients (18%) had CA125 level &lt;35 and 50 patients (82%) had CA125 level ≥35. ROMA index showed low risk in 17 patients (27,9%) and high risk 44 patients (72,1%). IOTA with M Rules was 51 patients (83,6%) and B rules was 10 patients (16,4%). Diagnostic value for ROMA score had sensitivity of 71,9%; RMI of 84,2%; and IOTA 82,5%. ROMA and IOTA accuracy was 68,9% and 92,2%, respectively. Conclusion : IOTA has better sensitivity in predicting ovarian tumour compared with ROMA. ROMA has higher positive predictive value compared with IOTA positive predictive value. ROMA negative predictive value is 5,9%, meanwhile for IOTA it is hard to determine Keywords: ovarian cancer, ROMA, IOTA, Ca-125, HE4

CYFRA 21-1 and Placental Growth Factor as Screening Markers for Endometriosis.

BackgroundThis study evaluated the performance of serum CYFRA 21-1 and placental growth factor (PIGF) as screening markers for endometriosis.Material/MethodsIn this prospective study included 81 female patients who underwent laparoscopy to treat benign ovarian tumors. Serum samples were obtained from all study patients before surgery. Serum marker levels, including CYFRA 21-1, PIGF, cancer antigen (CA)125, CA19-9, and human epididymis protein 4 (HE4) were measured using a fluorescence immunoassay technique.ResultsForty of the patients were diagnosed with endometriosis (the study group) and 41 women were diagnosed with other benign ovarian tumors (the control group). Mean serum CYFRA 21-1 and PIGF levels were not different between these 2 groups (P=0.179 and P=0.865, respectively). Elevated serum CA125 levels (>35 U/mL) and lower CYFRA 21-1 levels (≤2.29 ng/mL) were more frequently observed in the endometriosis study group than in the control group (P<0.0001, and P=048, respectively). High serum PIGF levels (>14.2 pg/mL) were observed in both groups (P=0.226). Mean serum CA19-9 levels and HE4 levels, as well as the ROMA (risk of ovarian malignancy Algorithm) score were similar between the 2 groups. Sensitivity (95.0%) and negative predictive value (NPV) (80.0%) of CYFRA 21-1 for diagnosing endometriosis were higher than those of CA125 (sensitivity 67.5%, NPV 74.5%) and PIGF (sensitivity 20.0%, NPV 53.6%). However, the specificity (PIGF 90.2%, CA125 92.7%) and positive predictive value (PPV) (PIGF 66.7%, CA125 87.1%) of PIGF and CA125 for diagnosing endometriosis were higher than those of CYFRA 21-1 (specificity 19.5%, PPV 53.5%).ConclusionsCYFRA 21-1 and PIGF may be promising markers to identify patients with and without ovarian endometriosis.

Comparison between Serum HE4 and CA125 as Tumor Markers in Premenopausal Women with Benign Pelvic Mass

The aim of the study was to evaluate the role of human epididymal secretory protein (HE4), cancer antigen 125 (CA125), and the Risk of Ovarian Malignancy Algorithm (ROMA) in diagnosing benign pelvic masses in premenopausal women. Serum was collected from 391 premenopausal women with benign pelvic mass prior to surgery and from 45 healthy individuals. Serum HE4 and CA125 levels and ROMA scores were evaluated separately. Among the 391 women with benign pelvic mass, 2.3% (9/391) had elevated HE4 levels (> 70 pmol/L), while 37.1% (145/391) had elevated CA125 levels (> 35 U/mL) (p < 0001). Endometriosis provided false-positive results for CA125 levels in more than half of the cases but resulted in no significant change for HE4 level. In 13 gravid women with a mass, 30.8% (4/13) and 38.5% (5/13) had elevated HE4 and CA125 levels, respectively; however, the difference was not significant (p > 0.05). Moreover, serum levels and patient percentages for CA125 elevation significantly increased with increase in mass diameter, whereas those for HE4 did not. CA125 elevation showed random results for benign pelvic masses, while HE4 elevation showed a higher specificity. Thus, serum HE4 testing is a better approach than CA125 testing for diagnosing benign pelvic masses in premenopausal women.

Multivariate Index Assay Is Superior to CA125 and HE4 Testing in Detection of Ovarian Malignancy in African-American Women.

Objective:To review and analyze the serum values of risk of ovarian malignancy algorithm (ROMA) and multivariate index assay (MIA) in subgroups of women who underwent surgery for adnexal masses to determine sensitivity, specificity, and positive and negative predictive values for the detection of malignancy in different ethnic populations.Methods:Serum samples from 2 prospective trials of 1029 women in which 274 women diagnosed with malignancy were analyzed for ROMA scores and MIA results. Biomarker data were obtained from the previous prospective studies that validated the MIA test. Of these, 250 women were Caucasian (C) and 24 were African-American (AA). Sensitivity, specificity, positive and negative predictive values, and confidence intervals for preoperative test results were calculated using DTComPair package of the R programming language. In premenopausal women, a ROMA value equal to or greater than 1.14 indicates a high risk of finding epithelial ovarian cancer. In premenopausal women, MIA values greater than 5.0 are associated with a greater risk of malignancy. In postmenopausal women, a ROMA value equal to or greater than 2.99 indicates a high risk of finding epithelial ovarian cancer. In postmenopausal women, MIA values greater than 4.4 are associated with a greater risk of malignancy.Results:Primary ovarian malignancy was diagnosed in 179 cases (167 C/12 AA) and metastatic disease to the ovary in an additional 27 cases (22 C/5 AA). Overall results are shown below.Conclusions:Our results demonstrate that ROMA in AA women with adnexal masses have lower sensitivity for the detection of malignancy than does MIA. Implementation of MIA in the evaluation of adnexal masses will increase the sensitivity of the detection of malignancy compared with ROMA, with the most marked results in AA women.

Correlation of ultrasound features and the Risk of Ovarian Malignancy Algorithm score for different histopathological subtypes of benign adnexal masses.

Ovarian masses are one of the most frequently identified entities in gynecological practice. Early differential diagnosis is a key factor in the medical management of each patient. Transvaginal ultrasound along with additional preoperative testing, such as serum cancer antigen 125 (CA-125) levels and the Risk of Ovarian Malignancy Algorithm (ROMA) score, usually provide sufficient information for a presumptive diagnosis. Minimally invasive surgery as a therapeutic approach is the standard procedure for uncomplicated and benign adnexal masses. Histopathological examination alone, or in conjunction with immunohistochemical testing establishes a more certain diagnosis in the final step of the patient management plan. We developed a retrospective descriptive observational study based on the evaluation of 107 patients admitted to the Department of Obstetrics and Gynecology at “Sf Pantelimon” Clinical Emergency Hospital in Bucharest between January 2000 and July 2017. Each patient was diagnosed with an ovarian mass and underwent laparoscopic surgery for treatment. All data underwent descriptive statistical analysis in order to establish correlations between preoperative test results and definitive diagnoses. The typical ultrasound findings of endometriotic cysts were histopathologically confirmed in 52.6% of the examined patients. Using ultrasound, benign teratomas were suspected in 66.6% of all documented dermoid cysts and 90% of the patients with a calculated ROMA score had corresponding values less than 15%. Mean CA-125 value was 26.58 U/mL. Laparoscopic surgery with ovarian cystectomy was performed for 78.5% of the cases. Histopathological examinations established endometriosis was present in 26.16% of cases. According to an independent samples t test (with 2 extreme values eliminated), patients in the premenopausal group had a significantly lower mean ROMA score than postmenopausal patients (6.87% vs 20.98%, respectively; P < .001). The groups had similar homogeneity (P = .131 according to the Levene test). Our results showed that transvaginal ultrasound established a presumptive diagnosis for almost half of our patients. Cystectomy was the main surgical procedure used for the management of benign ovarian masses. Endometriosis was the most common benign ovarian pathology evaluated and treated in our study.

Risk scores to guide referral decisions for people with suspected ovarian cancer in secondary care: a systematic review and cost-effectiveness analysis.

Ovarian cancer is the sixth most common cancer in UK women and can be difficult to diagnose, particularly in the early stages. Risk-scoring can help to guide referral to specialist centres. To assess the clinical and cost-effectiveness of risk scores to guide referral decisions for women with suspected ovarian cancer in secondary care. Twenty-one databases, including MEDLINE and EMBASE, were searched from inception to November 2016. Review methods followed published guidelines. The meta-analysis using weighted averages and random-effects modelling was used to estimate summary sensitivity and specificity with 95% confidence intervals (CIs). The cost-effectiveness analysis considered the long-term costs and quality-adjusted life-years (QALYs) associated with different risk-scoring methods, and subsequent care pathways. Modelling comprised a decision tree and a Markov model. The decision tree was used to model short-term outcomes and the Markov model was used to estimate the long-term costs and QALYs associated with treatment and progression. Fifty-one diagnostic cohort studies were included in the systematic review. The Risk of Ovarian Malignancy Algorithm (ROMA) score did not offer any advantage over the Risk of Malignancy Index 1 (RMI 1). Patients with borderline tumours or non-ovarian primaries appeared to account for disproportionately high numbers of false-negative, low-risk ROMA scores. (Confidential information has been removed.) To achieve similar levels of sensitivity to the Assessment of Different NEoplasias in the adneXa (ADNEX) model and the International Ovarian Tumour Analysis (IOTA) group's simple ultrasound rules, a very low RMI 1 decision threshold (25) would be needed; the summary sensitivity and specificity estimates for the RMI 1 at this threshold were 94.9% (95% CI 91.5% to 97.2%) and 51.1% (95% CI 47.0% to 55.2%), respectively. In the base-case analysis, RMI 1 (threshold of 250) was the least effective [16.926 life-years (LYs), 13.820 QALYs] and the second cheapest (£5669). The IOTA group's simple ultrasound rules (inconclusive, assumed to be malignant) were the cheapest (£5667) and the second most effective [16.954 LYs, 13.841 QALYs], dominating RMI 1. The ADNEX model (threshold of 10%), costing £5699, was the most effective (16.957 LYs, 13.843 QALYs), and compared with the IOTA group's simple ultrasound rules, resulted in an incremental cost-effectiveness ratio of £15,304 per QALY gained. At thresholds of up to £15,304 per QALY gained, the IOTA group's simple ultrasound rules are cost-effective; the ADNEX model (threshold of 10%) is cost-effective for higher thresholds. Information on the downstream clinical consequences of risk-scoring was limited. Both the ADNEX model and the IOTA group's simple ultrasound rules may offer increased sensitivity relative to current practice (RMI 1); that is, more women with malignant tumours would be referred to a specialist multidisciplinary team, although more women with benign tumours would also be referred. The cost-effectiveness model supports prioritisation of sensitivity over specificity. Further research is needed on the clinical consequences of risk-scoring. This study is registered as PROSPERO CRD42016053326. The National Institute for Health Research Health Technology Assessment programme.

Correlation of preoperative ROMA scores with clinical stage in epithelial ovarian cancer patients.

The significance of the Risk of Ovarian Malignancy Algorithm (ROMA) in differentiating benign and malignant ovarian lesions has been evidenced. In our clinical work, we found that advanced ovarian cancer were accompanied commonly with high ROMA scores. Thus, this study aimed to clarify the performance of ROMA in different disease stage of epithelial ovarian cancer (EOC) prior to surgery. Carbohydrate antigen (CA125) and human epididymis protein 4 (HE4) levels and ROMA scores in 221 patients with FIGO stage I, II or III/IV stage EOC were analyzed. The positive rates of CA125, HE4 and ROMA at each disease stage were calculated. Their cutoff values, sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) for distinguishing patients with FIGO stage I/II from those with FIGO stage III/IV were estimated via ROC curves. Serum CA125 and HE4 levels and ROMA scores rose significantly with advancing stage. ROMA and CA125 were significantly elevated more frequently in comparing with HE4 in EOC patients at with the same stage. Based on ROC curves, the cutoff values for FIGO stage III/IV EOC were 110IU/mL, 126pmol/L, 78 and 68% for CA125, HE4, premenopausal and postmenopausal ROMA, respectively. ROMA was the strongest predictor of FIGO stage, with the highest specificity, accuracy, and PPV, which were 84.4, 82.5, and 87.0% for postmenopausal patients, 89.3, 85.6, and 74.3% for premenopausal patients. Our data suggest high ROMA scores correlated with advanced ovarian cancer prior to surgery. These observations suggest potential utility of ROMA in the comprehensively preoperative evaluation of EOC patients.

Implementing the Risk of Ovarian Malignancy Algorithm Adding Obesity as a Predictive Factor.

To evaluate whether obesity represents a risk factor for the onset of ovarian cancer. One hundred and sixty-three patients with a body mass index (BMI) >30 kg/m2 (group 1) and 130 women with a BMI of <25 kg/m2 (group 2) were included in the study. A Risk of Ovarian Malignancy Algorithm (ROMA) index above the cut-off (>13%) was found in 24.5% of group 1 patients, whereas a high ROMA score was identified in 5.3% of group 2 women. During the study, 13 out of 40 group 1 patients with ROMA >13% were deemed eligible for bariatric surgery. After bariatric surgery and decrease of BMI, eight out of these 13 obese women had a ROMA index <13%. The ROMA index may function as a simple test able to screen obese women at risk of developing ovarian cancer.

Diagnostic performance and establishment of reference limits of HE4 in Korean healthy women

ObjectiveWe aimed to establish distribution and reference limits of HE4 and risk of ovarian malignancy algorithm (ROMA) in healthy Korean women and investigated the factors influencing HE4 levels. We also investigated the diagnostic performances of HE4 and ROMA score, compared with CA125. MethodsWe collected specimens from 1809 healthy Korean women, 140 specimens from patients with ovarian cancers (OCs) and 123 specimens from patients with benign ovarian tumor. Serum HE4 and CA125 concentrations were measured using an electrochemiluminescence immunoassay. The receiver operator characteristic (ROC) curve analysis was done for ROMA, HE4, CA125 and combining of HE4 and CA125. ResultsHE4 level was influenced by age, not by menopausal status. The 97.5th percentile upper reference limit of HE4 of subjects <50years and ≥50year-old was 63.87pmol/L and 88.28pmol/L, respectively. The 97.5th percentile upper reference limits of ROMA score were 13.66 in premenopausal and 19.30 in postmenopausal women. The serum HE4 level was even lower in the patients with benign tumor compared to those in healthy controls. HE4 had significantly higher concentrations in OCs than benign ovarian tumor (P<0.001). ROMA and HE4 combined with CA125 or not performed better diagnostically than CA125 alone for distinguishing OCs, with AUCs of 0.844 for ROMA, 0.827 for combining of HE4 and CA125, 0.825 for HE4, and 0.795 for CA125. ConclusionsThe reference limit of HE4 was different from those reported by other studies, suggesting racial or regional difference. HE4 and ROMA were better than CA125 for differentiation normal and benign ovarian tumor from OCs. (Word count: 253)

Is the Risk of Ovarian Malignancy Algorithm Better Than Other Tests for Predicting Ovarian Malignancy in Women with Pelvic Masses?

Aim: The study aimed to compare the risk of ovarian malignancy algorithm (ROMA) with risk of malignancy index (RMI), cancer antigen 125 (CA125), human epididymis protein 4 (HE4) and Sassone ultrasonography (US) score in predicting ovarian cancer (OC) in women who present with pelvic or adnexal masses. Methods: Pelvic US, serum CA125 and HE4 levels were investigated preoperatively in consecutively enrolled Thai women over 18 years with clinically diagnosed pelvic or adnexal masses who were undergoing elective surgery at a super tertiary hospital in Thailand in 2012. ROMA, RMI and Sassone US score were calculated. Results: Of 260 women who were evaluated, 74 had OC. Areas under the receiver operating characteristic curve (AUC) in predicting OC were ROMA, 86.2%; RMI, 87.6%; CA125, 80.6%; HE4, 82.4%; and Sassone score, 77.1%. ROMA and RMI performed similarly well (AUCs 84.4 and 85.6%) in premenopausal women but RMI outperformed ROMA in postmenopausal women (AUCs 87.9 and 84.0%, respectively). At the conventional cutoff value, ROMA and CA125 showed the highest sensitivity (83.8%) but HE4 had the highest specificity (86.0%). Conclusions: ROMA was comparable to RMI in predicting OC. Either ROMA or RMI can be applied to women with pelvic masses, stratified into low- and high-risk groups for OCs.

Clinical value of human epididymis protein 4 and the Risk of Ovarian Malignancy Algorithm in differentiating borderline pelvic tumors from epithelial ovarian cancer in early stages

ObjectiveThe clinical value of human epididymis protein 4 (HE4) and the possibility of its use in the differential diagnosis in patients with benign, borderline and epithelial ovarian cancer in early International Federation of Gynaecology and Obstetrics (FIGO) stages. Study designThe study group consisted of 205 women, including 60 with ovarian cancer, 18 with borderline tumors, 77 with benign lesions and 50 healthy subjects. In all the patients, before the treatment and in control groups, we determined CA 125 and HE4 in serum by electrochemiluminescence on the basis of the COBAS e601 system. For comparison of two independent groups, we used the U Mann–Whitney test. The analysis of the diagnostic power of the assessed parameters has been determined using the MedCalc statistical program. The probability of disease free survival (DFS) was evaluated using the log-rank test and Cox regression model. ResultsConcentrations of HE4, CA 125 and Risk of Ovarian Malignancy Algorithm (ROMA) value were significantly higher in early ovarian cancer than in patients with benign (P<0.0001) and borderline tumors (P<0.002), the receiver operating characteristics (ROC) curves, demonstrated the highest diagnostic sensitivity for the ROMA score, as well post (AUC=0.817) as pre-menopausal (AUC=0.806). HE4 concentrations (P<0.021) and the value of the ROMA score (P<0.004) were significantly higher in patients with relapse than in patients in remission. There was no connection between concentrations of the studied tumor markers and DFS. ConclusionsDetermination of HE4 serum concentrations has a significant clinical value, especially in patients with benign lesions and elevated CA 125 levels. The combined assessment of HE4, CA 125 and the ROMA algorithm is helpful in differentiating benign tumors and borderline pelvic tumors from epithelial ovarian cancer in early FIGO stages. Determination of HE4, CA 125 and ROMA algorithm is not helpful in differentiating patients with borderline from benign lesions.