Development and validation of a model that includes two ultrasound parameters and the plasma D-dimer level for predicting malignancy in adnexal masses: an observational study
Abstract Background Pre-operative discrimination of malignant from benign adnexal masses is crucial for planning additional imaging, preparation, surgery and postoperative care. This study aimed to define key ultrasound and clinical variables and develop a predictive model for calculating preoperati...
| Main Authors: | , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2019-06-01
|
| Series: | BMC Cancer |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12885-019-5629-x |
| _version_ | 1819209631210143744 |
|---|---|
| author | Maciej Stukan Michał Badocha Karol Ratajczak |
| author_facet | Maciej Stukan Michał Badocha Karol Ratajczak |
| author_sort | Maciej Stukan |
| collection | DOAJ |
| description | Abstract Background Pre-operative discrimination of malignant from benign adnexal masses is crucial for planning additional imaging, preparation, surgery and postoperative care. This study aimed to define key ultrasound and clinical variables and develop a predictive model for calculating preoperative ovarian tumor malignancy risk in a gynecologic oncology referral center. We compared our model to a subjective ultrasound assessment (SUA) method and previously described models. Methods This prospective, single-center observational study included consecutive patients. We collected systematic ultrasound and clinical data, including cancer antigen 125, D-dimer (DD) levels and platelet count. Histological examinations served as the reference standard. We performed univariate and multivariate regressions, and Bayesian information criterion (BIC) to assess the optimal model. Data were split into 2 subsets: training, for model development (190 observations) and testing, for model validation (n = 100). Results Among 290 patients, 52% had malignant disease, including epithelial ovarian cancer (72.8%), metastatic disease (14.5%), borderline tumors (6.6%), and non-epithelial malignancies (4.6%). Significant variables were included into a multivariate analysis. The optimal model, included three independent factors: solid areas, the color score, and the DD level. Malignant and benign lesions had mean DD values of 2.837 and 0.354 μg/ml, respectively. We transformed established formulae into a web-based calculator (http://gin-onc-calculators.com/gynonc.php) for calculating the adnexal mass malignancy risk. The areas under the curve (AUCs) for models compared in the testing set were: our model (0.977), Simple Rules risk calculation (0.976), Assessment of Different NEoplasias in the adneXa (ADNEX) (0.972), Logistic Regression 2 (LR2) (0.969), Risk of Malignancy Index (RMI) 4 (0.932), SUA (0.930), and RMI3 (0.912). Conclusions Two simple ultrasound predictors and the DD level (also included in a mathematical model), when used by gynecologist oncologist, discriminated malignant from benign ovarian lesions as well or better than other more complex models and the SUA method. These parameters (and the model) may be clinically useful for planning adequate management in the cancer center. The model needs substantial validation. |
| first_indexed | 2024-12-23T05:58:21Z |
| format | Article |
| id | doaj.art-c28bc3247bc74976992e409d14b06b8b |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-23T05:58:21Z |
| publishDate | 2019-06-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-c28bc3247bc74976992e409d14b06b8b2022-12-21T17:57:44ZengBMCBMC Cancer1471-24072019-06-0119111210.1186/s12885-019-5629-xDevelopment and validation of a model that includes two ultrasound parameters and the plasma D-dimer level for predicting malignancy in adnexal masses: an observational studyMaciej Stukan0Michał Badocha1Karol Ratajczak2Department of Gynecologic Oncology, Gdynia Oncology Center, Pomeranian Hospitals, Gdynia, PolandDepartment of Physical Chemistry, Gdańsk University of Technology, Gdańsk, PolandKarol Ratajczak ConsultingAbstract Background Pre-operative discrimination of malignant from benign adnexal masses is crucial for planning additional imaging, preparation, surgery and postoperative care. This study aimed to define key ultrasound and clinical variables and develop a predictive model for calculating preoperative ovarian tumor malignancy risk in a gynecologic oncology referral center. We compared our model to a subjective ultrasound assessment (SUA) method and previously described models. Methods This prospective, single-center observational study included consecutive patients. We collected systematic ultrasound and clinical data, including cancer antigen 125, D-dimer (DD) levels and platelet count. Histological examinations served as the reference standard. We performed univariate and multivariate regressions, and Bayesian information criterion (BIC) to assess the optimal model. Data were split into 2 subsets: training, for model development (190 observations) and testing, for model validation (n = 100). Results Among 290 patients, 52% had malignant disease, including epithelial ovarian cancer (72.8%), metastatic disease (14.5%), borderline tumors (6.6%), and non-epithelial malignancies (4.6%). Significant variables were included into a multivariate analysis. The optimal model, included three independent factors: solid areas, the color score, and the DD level. Malignant and benign lesions had mean DD values of 2.837 and 0.354 μg/ml, respectively. We transformed established formulae into a web-based calculator (http://gin-onc-calculators.com/gynonc.php) for calculating the adnexal mass malignancy risk. The areas under the curve (AUCs) for models compared in the testing set were: our model (0.977), Simple Rules risk calculation (0.976), Assessment of Different NEoplasias in the adneXa (ADNEX) (0.972), Logistic Regression 2 (LR2) (0.969), Risk of Malignancy Index (RMI) 4 (0.932), SUA (0.930), and RMI3 (0.912). Conclusions Two simple ultrasound predictors and the DD level (also included in a mathematical model), when used by gynecologist oncologist, discriminated malignant from benign ovarian lesions as well or better than other more complex models and the SUA method. These parameters (and the model) may be clinically useful for planning adequate management in the cancer center. The model needs substantial validation.http://link.springer.com/article/10.1186/s12885-019-5629-xOvarian cancerUltrasoundD-dimerCalculationDiagnosis, differentialSensitivity and specificity |
| spellingShingle | Maciej Stukan Michał Badocha Karol Ratajczak Development and validation of a model that includes two ultrasound parameters and the plasma D-dimer level for predicting malignancy in adnexal masses: an observational study BMC Cancer Ovarian cancer Ultrasound D-dimer Calculation Diagnosis, differential Sensitivity and specificity |
| title | Development and validation of a model that includes two ultrasound parameters and the plasma D-dimer level for predicting malignancy in adnexal masses: an observational study |
| title_full | Development and validation of a model that includes two ultrasound parameters and the plasma D-dimer level for predicting malignancy in adnexal masses: an observational study |
| title_fullStr | Development and validation of a model that includes two ultrasound parameters and the plasma D-dimer level for predicting malignancy in adnexal masses: an observational study |
| title_full_unstemmed | Development and validation of a model that includes two ultrasound parameters and the plasma D-dimer level for predicting malignancy in adnexal masses: an observational study |
| title_short | Development and validation of a model that includes two ultrasound parameters and the plasma D-dimer level for predicting malignancy in adnexal masses: an observational study |
| title_sort | development and validation of a model that includes two ultrasound parameters and the plasma d dimer level for predicting malignancy in adnexal masses an observational study |
| topic | Ovarian cancer Ultrasound D-dimer Calculation Diagnosis, differential Sensitivity and specificity |
| url | http://link.springer.com/article/10.1186/s12885-019-5629-x |
| work_keys_str_mv | AT maciejstukan developmentandvalidationofamodelthatincludestwoultrasoundparametersandtheplasmaddimerlevelforpredictingmalignancyinadnexalmassesanobservationalstudy AT michałbadocha developmentandvalidationofamodelthatincludestwoultrasoundparametersandtheplasmaddimerlevelforpredictingmalignancyinadnexalmassesanobservationalstudy AT karolratajczak developmentandvalidationofamodelthatincludestwoultrasoundparametersandtheplasmaddimerlevelforpredictingmalignancyinadnexalmassesanobservationalstudy |