Introduction/Background Recently, ESGO/ISUOG/IOTA/ESGE Consensus Statement on pre-operative diagnosis of ovarian tumors implied that neither Human epididymis protein 4 (HE4) nor Risk of Ovarian Malignancy Algorithm (ROMA) improve the discrimination between benign and malignant masses compared with CA 125 alone. This statement might be reassessed if a novel algorithm, more effective than ROMA, will be implemented. Thereby the aim of this study was to validate a new predictive algorithm, based on serum CA125&HE4. Methodology A novel Risk of Ovarian Cancer Kazan Index (ROCK-I), based on serum HE4, CA125 and patient's age as variables, has been developed using a training dataset (n=284). ROCK-I provides an estimation of the risk of malignancy of adnexal mass in premenopausal patients. The validating dataset consisted of 333 consecutively operated premenopausal patients with pelvic mass out of which there were 281 cases of benign diseases, 43 cancers and 9 borderline ovarian tumors (BOT). Results on the validating dataset are reported below. Results When benign diseases vs all cancers and BOT were considered, ROC-AUC of ROCK-I, ROMA and CA 125 in the validating dataset were 0.917, 0.864 and 0.874 respectively. When benign diseases vs all cancers and stages Ic2-III of BOT were considered, ROC-AUC were 0.96, 0.911 and 0.896 respectively. The superiority of ROCK-I was statistically significant over both ROMA (p=0.003) and CA 125 (p=0.002). When standard cut-off levels were applied the specificities of ROCK-I and ROMA were 93.5 and 85.1%, and the sensitivities for all cancers were 93 and 86% respectively. The performance of ROCK-I and ROMA in different scenarios of discrimination is shown in table 1. Conclusion ROMA provides suboptimal discrimination at least among premenopausal patients. If a large independent validation shows similar or even slightly lower superiority of the novel ROCK-I over ROMA, it may provide a new basis of routine-use of HE4 in premenopausal patients with pelvic mass. Disclosures Authors has nothing to disclosure

Introduction/Background Recently, ESGO/ISUOG/IOTA/ESGE Consensus Statement on pre-operative diagnosis of ovarian tumors implied that neither Human epididymis protein 4 (HE4) nor Risk of Ovarian Malignancy Algorithm (ROMA) improve the discrimination between benign and malignant masses compared with CA 125 alone. This statement may be reassessed if a novel algorithm, more powerful than ROMA, will be developed. Thereby the aim of this study was to elaborate a new predictive algorithm, based on serum CA125&HE4, which performs better than ROMA Methodology A novel algorithm, based on serum HE4, CA125 and patient's age as variables, has been developed using a training dataset. This algorithm was named Risk of Ovarian Cancer Kazan Index (ROCK-I). The validating group consisted of 227 consecutively operated premenopausal patients with pelvic mass out of which there were 193 cases of benign diseases, 27 cancers and 7 borderline ovarian tumors (BOT). Results ROCK-I demonstrated two fold less false positive results than ROMA. Thus, in the validating dataset, there was a statistically significant superiority of ROCK-I over ROMA in the specificity (92.2% and 84.5% respectively, p=0.017). Meanwhile, the sensitivity of ROCK-I was also numerically higher in all the scenarios of discrimination (table 1). When the scenario of discrimination 'benign disease vs the joint group of EOC (all stages) together with BOT stage Ic2-III' was used, ROC-AUC of ROCK-I, ROMA and CA 125 were 0.988, 0.946 and 0.937 respectively (figure 1). The difference in ROC-AUC between ROCK-I and CA125 was statistically significant (p=0.01) while the difference between ROMA and CA125 was not (p=0.79). Conclusion ROMA provides a suboptimal prediction, at least, in premenopausal patients. If a large independent validation shows similar or even slightly lower superiority of the novel ROCK-I over ROMA, it may provide a new basis of routine-use of HE4 in the preoperative assessment of premenopausal patients with pelvic mass.

Objective: to elaborate a new algorithm, based on serum CA125, HE4 and age, to assess the risk of malignancy in premenopausal patients with pelvic mass, which performs better than Risk of Ovarian Malignancy Algorithm (ROMA).Materials and methods. The training dataset included 284 premenopausal patients operated because of the presence of pelvic mass, out of which there were 249 patients with benign diseases and 35 patients with malignant or borderline tumors. A novel algorithm, based on serum HE4, CA125 and patient’s age as variables, has been developed. This algorithm was named Risk of Ovarian Cancer Kazan Index (ROCK-I). The validating dataset consisted of 227 consecutively operated premenopausal patients with pelvic mass out of which there were 193 cases of benign diseases, 27 cancers and 7 borderline ovarian tumors (BOT).Results. In the validating dataset ROCK-I and ROMA demonstrated 15 and 30 false positive results respectively. Thus the specificities of ROCK-I and ROMA were 92.2 % and 84.5 %, respectively (р = 0.017). The sensitivities of ROCK-I and ROMA for the joint group of Epithelial ovarian cancers (EOC) (all stages) together with BOT stage IC2–III were 96.3 % and 92.6 %, respectively (p = 0.55). For all malignant disease (all stages) together with BOT stage IC2–III the sensitivities were 90 % and 86.7 %, respectively (p = 0.69). The positive predictive values of ROCK-I and ROMA were 65.1 % and 47.4 %, respectively (p = 0.07). When the scenario of discrimination “benign disease vs the joint group of EOC (all stages) together with BOT stage IC2–III” was used, ROC-AUC of ROCK-I, ROMA and CA125 were 0.988, 0.946 and 0.937. The difference in ROC-AUC between ROCK-I and CA125 was statistically significant (p = 0.01) while the difference between ROMA and CA125 was not (p = 0.79).Conclusion. The proposed ROCK-I has demonstrated greater diagnostic performance than both ROMA and CA125 in the analyzed dataset. If an independent validation shows similar or even slightly lower superiority of ROCK-I over ROMA, it may provide a new basis of routine-use of HE4 in premenopausal patients with pelvic mass.

Introduction/Background* Human epididymis protein 4 (HE4) has been reported as a promizing biomarker in the assessment of the risk of malignancy in patients, diagnosed with pelvic mass. Howewer, reference limits of HE4 do not provide clinically relevant discrimination between malignant and benign ovarian diseases. The clinical significance of well-known Risk of Ovarian Malignancy Algorithm (ROMA), which includes both HE4 and CA125, and its superiority over CA125 alone are still questionable. The aim of this study was to elaborate a new algorithm, based on serum CA125, HE4 and age, to assess the risk of malignancy in premenopausal patients with pelvic mass Methodology The training dataset included 284 premenopausal patients operated because of presence of pelvic mass, out of which 35 and 249 had malignant and benign disease respectively. A novel algorithm, based on serum HE4, CA125 and patient's age as variables, has been developed by using the scenario of discrimination "benign diseases versus all stages of epithelial ovarian cancer (EOC) together with borderline ovarian tumors (BOT) FIGO stage 1c2–3c". This algorithm was named Risk of Ovarian Cancer Kazan Index (ROCK-I). The validating dataset consisted of consecutively operated premenopausal patients with pelvic mass out of which there were 187 cases of benign diseases, 20 EOC and 4 BOT FIGO stage 1c2–3c. An analysis with inclusion of BOT stage 1a-1c1 and non-EOC will be reported separately. Result(s)* In the validating dataset the specificities of ROCK-I and ROMA were 92% and 85% respectively (p<0.05). When the above-mentioned scenario of discrimination was used the sensitivities of ROCK-I and ROMA were 95.8% and 91.7% respectively, accuracies 92.4 and 85.8%, positive predictive values 60.5% and 44% respectively. Areas under receiver-operating-characteristic curves (ROC-AUC) of ROCK-I, ROMA and CA125 were 0.984, 0.94 and 0.901 respectively. The difference in ROC-AUC between ROCK-I and CA125 was statistically significant (p=0.03). A more detailed comparison of the performance of algorithms is shown in table 1 and figure 1. Conclusion* The proposed ROCK-I has demonstrated greater diagnostic performance than both ROMA and CA125 in the analyzed dataset. If an independent validation will show similar or even slightly lower difference between ROCK-I and ROMA it may provide a new basis of routine-use of HE4 in premenopausal patients with pelvic mass.

This European consensus statement on essential colposcopy provides standards for the general colposcopist seeing women referred for colposcopy with an abnormal cervical screening test (including cytology and HPV tests) or with a clinically suspicious cervix. The article gives guidance regarding the aims and conduct of colposcopy. Recommendations are provided on colposcopy technique, the management of common colposcopy issues, treatment and follow-up of after treatment of CIN or early stage cervical. Colposcopists should make an informed decision on the management of each individual that is referred and organize appropriate follow-up. Cervical cancer is still a major health issue and the quality of care can only improve if there is a structured guidance for women with an abnormal smear or suspicious cervix.

Introduction/Background Several studies has shown no advantages of Risk of Ovarian Malignancy Algorithm (ROMA) over CA125 and/or HE4 tumor markers alone when ROC-AUC were analyzed. However, the best way of clinical interpretation of CA125/HE4 levels remains unclear. The goal of the study was to comprehensively evaluate several ways of clinical interpretation of CA125/HE4 serum levels in patients with pelvic mass. Methodology We analyzed Ca125 and HE4 serum levels in 145 healthy females and in 1019 patients with pelvic mass, scheduled to have surgery. Results In healthy women 95th percentile (90% Confidence Interval) of HE4 levels were 38.5(37.5–41.2) and 45.8(41.6–48.1) pmol/L in pre- and post-menopause respectively. When the manufacturer’s reference limits were used as a threshold, HE4 showed a sensitivity for epithelial ovarian cancer of 54% and a specificity of 98.8%. When our local reference population’s reference limits were used, the sensitivity and specificity of HE4 were of 94.7% and of 55.9% respectively. CA125 showed a sensitivity of 96.7% and a specificity of 73.7% according to the 35 U/ml threshold. The sensitivity and specificity of ROMA according to its standard cut-off limits were 89.2 and 88% respectively. Even when calculated optimal cut-off levels of CA125 and HE4 and standard cut-off level for ROMA were used, ROMA showed a tendency to a higher performance and a more balanced sensitivity/specificity than CA125/HE4 alone. Conclusion Reference limits of CA125/HE4 (not proposed by the manufacturer, not determined in a reference population) do not correspond to the optimal cut-off levels and are not of clinical significance in patients with pelvic mass. ROMA performs better in a clinical setting than CA125/HE4 alone even if optimized cut-off levels (instead of reference limits) of these markers are used. Disclosure Nothing to disclose.

Introduction/Background Presently, a few organizational patterns of screening against cervical cancer (CC) coexist in Russia. These include organized screening under a federal governmental program, opportunistic screening on visiting a gynecologist, obligatory annual medical checkup of working class people with inclusion of Pap-test for women and some regional programs.The objectives of this observational study were: (1) to evaluate shortcomings and faults of the screening chain (attendance to a primary screening, screening test performance, management of abnormal results of cervical cytology, follow up after treatment etc.) and a gynecologic care which lead to invasive CC development or late diagnosis in Tatarstan (Russian Federation); (2) to evaluate the effectiveness and limitations of different organizational patterns of CC screening. Methodology Ninety consecutive patients with newly diagnosed invasive CC in the Tatarstan Cancer Center (Kazan, Russia) were carefully interviewed on their anamnesis morbi, previous screening history, history of attendance to governmental or private gynecologic care, history of their Pap-smears and other details. Medical records from primary hospitals and Pap-smear results for five years prior to the CC diagnosis were evaluated, where possible. Histology and stage of diseases were also analyzed. Results Within 3 years before CC diagnosis only 14 (15.5%) patients had not visit no gynecologist no medical check-up with inclusion of gynecologic examination. Conclusion Non-attendance to CC screening is not a main cause of cervical cancer occurrence in Russia. Faults in the management of abnormal results of Pap-test are the common causes of CC development and late diagnosis. Organized screening offered by the federal governmental program is a best way of CC screening organization in Russia. A well organized service (within the healthcare system) aimed on managing patients with abnormal results of Pap-smear, their subsequent treatment and follow up is needed. Disclosure Nothing to disclose