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Certified reference materials (CRMs) with high accuracy and traceability play a significant role in the calibration of equipment and validation of analytical methods. However, there is still a lack of suitable solid waste CRMs for quality assurance and quality control. Thus, a CRM (GBW(E)085538) was developed for accurate determination and reliable measurement of the leaching of Pb and Zn in solid waste according to the requirements of ISO 17034 and the recommendations of ISO Guide 35. This study describes the steps performed for the development of the CRM. These steps include material preparation, homogeneity, and stability during transport and storage, assignment of certified values, and their uncertainties. The material was dried, ground, sieved and well-mixed, and the final bulk material was bottled in 1 kg portions. Analytical techniques like inductively coupled plasma-mass spectrometry (ICP-MS), inductively coupled plasma-optical emission spectrometry (ICP-OES), and flame atomic absorption spectrometry (AAS) have been used for the characterization of property values. Concurrently, an inter-laboratory comparison study involving 9 qualified laboratories was implemented to support the certification study. The certified values of Pb and Zn were (4.66 ± 0.21) mg/L and (2.95 ± 0.14) mg/L with 7-month stability.
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PURPOSE: To establish a nomogram integrating radiomics features based on ultrasound images and clinical parameters for predicting the prognosis of patients with endometrial cancer (EC). MATERIALS AND METHODS: A total of 175 eligible patients with ECs were enrolled in our study between January 2011 and April 2018. They were divided into a training cohort (n = 122) and a validation cohort (n = 53). Least absolute shrinkage and selection operator (LASSO) regression were applied for selection of key features, and a radiomics score (rad-score) was calculated. Patients were stratified into high risk and low-risk groups according to the rad-score. Univariate and multivariable COX regression analysis was used to select independent clinical parameters for disease-free survival (DFS). A combined model based on radiomics features and clinical parameters was ultimately established, and the performance was quantified with respect to discrimination and calibration. RESULTS: Nine features were selected from 1130 features using LASSO regression in the training cohort, which yielded an area under the curve (AUC) of 0.823 and 0.792 to predict DFS in the training and validation cohorts, respectively. Patients with a higher rad-score were significantly associated with worse DFS. The combined nomogram, which was composed of clinically significant variables and radiomics features, showed a calibration and favorable performance for DFS prediction (AUC 0.893 and 0.885 in the training and validation cohorts, respectively). CONCLUSION: The combined nomogram could be used as a tool in predicting DFS and may assist individualized decision making and clinical treatment.
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Neoplasias Endometriales , Humanos , Femenino , Neoplasias Endometriales/diagnóstico por imagen , Ultrasonografía , NomogramasRESUMEN
OBJECTIVES: To investigate the prognostic role of magnetic resonance imaging (MRI)-based radiomics signature and clinical characteristics for overall survival (OS) and disease-free survival (DFS) in the early-stage cervical cancer. METHODS: A total of 207 cervical cancer patients (training cohort: n = 144; validation cohort: n = 63) were enrolled. 792 radiomics features were extracted from T2W and diffusion-weighted imaging (DWI). 19 clinicopathological parameters were collected from the electronic medical record system. Least absolute shrinkage and selection operator (LASSO) regression analysis was used to select significant features to construct prognostic model for OS and DFS. Kaplan-Meier (KM) analysis and log-rank test were applied to identify the association between the radiomics score (Rad-score) and survival time. Nomogram discrimination and calibration were evaluated as well. Associations between radiomics features and clinical parameters were investigated by heatmaps. RESULTS: A radiomics signature derived from joint T2W and DWI images showed better prognostic performance than that from either T2W or DWI image alone. Higher Rad-score was associated with worse OS (p < 0.05) and DFS (p < 0.05) in the training and validation set. The joint models outperformed both radiomics model and clinicopathological model alone for 3-year OS and DFS estimation. The calibration curves reached an agreement. Heatmap analysis demonstrated significant associations between radiomics features and clinical characteristics. CONCLUSIONS: The MRI-based radiomics nomogram showed a good performance on survival prediction for the OS and DFS in the early-stage cervical cancer. The prediction of the prognostic models could be improved by combining with clinical characteristics, suggesting its potential for clinical application. ADVANCES IN KNOWLEDGE: This is the first study to build the radiomics-derived models based on T2W and DWI images for the prediction of survival outcomes on the early-stage cervical cancer patients, and further construct a combined risk scoring system incorporating the clinical features.
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Imagen de Difusión por Resonancia Magnética , Imágenes de Resonancia Magnética Multiparamétrica , Neoplasias del Cuello Uterino/diagnóstico por imagen , Neoplasias del Cuello Uterino/patología , Supervivencia sin Enfermedad , Femenino , Estudios de Seguimiento , Humanos , Estimación de Kaplan-Meier , Estadificación de Neoplasias , Nomogramas , Reproducibilidad de los ResultadosRESUMEN
OBJECTIVES: To investigate the prognostic role of radiomic features based on pretreatment MRI in predicting progression-free survival (PFS) of locally advanced cervical cancer (LACC). METHODS: All 181 women with histologically confirmed LACC were randomly divided into the training cohort (n = 126) and the validation cohort (n = 55). For each patient, we extracted radiomic features from whole tumors on sagittal T2WI and axial DWI. The least absolute shrinkage and selection operator (LASSO) algorithm combined with the Cox survival analysis was applied to select features and construct a radiomic score (Rad-score) model. The cutoff value of the Rad-score was used to divide the patients into high- and low-risk groups by the X-tile. Kaplan-Meier analysis and log-rank test were used to assess the prognostic value of the Rad-score. In addition, we totally developed three models, the clinical model, the Rad-score, and the combined nomogram. RESULTS: The Rad-score demonstrated good performance in stratifying patients into high- and low-risk groups of progression in the training (HR = 3.279, 95% CI: 2.865-3.693, p < 0.0001) and validation cohorts (HR = 2.247, 95% CI: 1.735-2.759, p < 0.0001). Otherwise, the combined nomogram, integrating the Rad-score and patient's age, hemoglobin, white blood cell, and lymph vascular space invasion, demonstrated prominent discrimination, yielding an AUC of 0.879 (95% CI, 0.811-0.947) in the training cohort and 0.820 (95% CI, 0.668-0.971) in the validation cohort. The Delong test verified that the combined nomogram showed better performance in estimating PFS than the clinical model and Rad-score in the training cohort (p = 0.038, p = 0.043). CONCLUSION: The radiomics nomogram performed well in individualized PFS estimation for the patients with LACC, which might guide individual treatment decisions.
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PURPOSE: More than 80% of patients with ovarian epithelial cancer (OEC) show complete remission after initial treatment but eventually experience recurrence of the disease. This study aimed to develop a radiomics signature to identify a new prognostic indicator based on preoperative ultrasound imaging. METHODS: A total of 111 patients with OEC who underwent transvaginal ultrasound before surgery were included. Of these, 76 were divided into the training cohort and 35 into the test cohort. We defined the region of interest (ROI) of the tumor by manually drawing the tumor contour on the ultrasound image of the lesion. The radiomics features were extracted from ultrasound images. The radiomics score (Rad-Score) was constructed using the least absolute shrinkage and selection operator (LASSO) analysis and Cox regression. Combined with the ultrasound radiomics features, significant clinical variables were also used to establish predictive models for 5-year progression-free survival (PFS) prediction. The efficiency of the model was evaluated using the area under the curve (AUC). Kaplan-Meier analysis was used to evaluate the association between the Rad-Score and PFS. RESULTS: The combined model was superior to the clinical and Rad-Score models in estimating 5-year PFS and achieved an AUC of 0.868 (95%CI 0.766-0.971) in the training cohort. The Rad-Score was negatively correlated with prognosis in the training and test cohorts. CONCLUSIONS: The combined model that incorporated both clinical parameters and ultrasound radiomics features achieved a good prognosis in patients with OEC, which might aid clinical decision-making.
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Nomogramas , Neoplasias Ováricas , Biomarcadores , Carcinoma Epitelial de Ovario/diagnóstico por imagen , Femenino , Humanos , Recurrencia Local de Neoplasia , Neoplasias Ováricas/diagnóstico por imagen , Supervivencia sin Progresión , UltrasonografíaRESUMEN
OBJECTIVE: To introduce a special case of endometrial cavity fluid (ECF), highlighting the application of hysteroscopy and laparoscopic surgical techniques in the treatment of cervical sinus tract. DESIGN: Narrated video featuring the diagnosis and surgical management of a case of recurrent ECF. Informed consent was obtained from the patient, and approval was granted by the ethics committee of the First Affiliated Hospital of the Wenzhou Medical University. SETTING: Academic tertiary hospital. PATIENT(S): A 36-year-old woman, gravida 0, had menstrual spotting for 13 years after abdominal myomectomy of a 104 × 86 × 111-mm myoma on the posterior uterine wall near the cervix. She failed to conceive after her marriage for 10 years, and 5 operations, including hysteroscopy and laparoscopy, were performed to increase pregnancy opportunities. She also underwent in vitro fertilization and embryo transfer procedures many times, but failed. Transvaginal sonography preoperatively suggested that ECF sometimes appeared and sometimes disappeared. The local echo of the posterior wall of the cervix was enhanced. A 40-mm cystic dark area was found beside the right ovary, which seemed to connect with the cervical hyperechoic part. Additionally, a solid mass of the right adnexa with abundant blood supply was detected. INTERVENTION(S): First, hysteroscopy was performed to explore the ECF. A deep and narrow cervical sinus with a steady stream of accumulated blood overflowed in the lower part of the cervix, and a normal uterine cavity was found. Laparoscopic adhesiolysis and enucleation of the cystic structure that connected to the sinus tract then were performed. Hysteroscopy was repeated to determine the thinnest cervical region by the light transmission test. A horizontal incision was made on the thinnest layer. Scar tissues were removed. The incision was sutured in full layer intermittently and continuously under laparoscopy. The postoperative thickness of the muscular layer in the sinus was confirmed by light transmission test of hysteroscopy. The patient was discharged on the third day after operation, uneventfully. Histopathologic examination showed that the cystic structure and scar tissue contained smooth muscle tissue and were covered by both mucinous columnar epithelium of the cervical canal and endometrial glandular epithelium. MAIN OUTCOME MEASURE(S): Restoration of normal anatomy, removal of uterine effusion, and symptomatic relief. RESULT(S): At the 6-month follow-up, the patient's menstrual cycles returned to normal without the recurrence of menstrual spotting. The ultrasound scan also showed a symmetrical uterus without ECF. CONCLUSION(S): Patients with ECF who underwent assisted reproductive surgeries were related to the poor prognosis. However, the treatment should be different according to the causes, appearance time, and accumulation amount, including expectant treatment, postponement of embryo transfer, transvaginal aspiration, laparoscopic salpingectomy, or proximal tubal occlusion. For patients with recurrent ECF and/or special appearance on ultrasound, endoscopic examination is necessary. In addition, patients with large myomas at difficult locations required a uniform strategy to reduce the intraoperative and postoperative complications, especially for the nulligravida women.
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Líquidos Corporales/fisiología , Cuello del Útero/diagnóstico por imagen , Endometrio/fisiopatología , Histeroscopía/métodos , Infertilidad Femenina/terapia , Adulto , Cuello del Útero/cirugía , Femenino , Humanos , Recurrencia , UltrasonografíaRESUMEN
OBJECTIVE: Lipids have been evaluated for their possible role in cancer survival prediction. The aim of the current study was to investigate the prognostic value of lipids on overall survival for stage IB1-IIA2 cervical cancer patients. METHODS: A retrospective study including cervical cancer patients with early-stage (FIGO 2009 stage IB1-IIA2) disease was conducted from January 2012 to February 2017. Patients with any history of liver disease or other cancers, and patients who took any medications known to influence lipid metabolism, were excluded. We measured various factors in patients' lipid profiles including total cholesterol, triglycerides, high-density lipoprotein, and low-density lipoprotein, and assessed these four parameters together with clinicopathological features to identify the significant prognostic factors for overall survival. RESULTS: A total of 583 patients with median age 53 (range 25-82) years were included. Among them, 283 (48.5%) patients were in FIGO stage IB1, 44 patients (7.6%) in stage IB2, 189 (32.4%) patients in stage IIA1, and the remaining 67 (11.5%) patients were in stage IIA2. Using univariable Cox proportional hazard analysis and subsequent multivariable analysis, total cholesterol, triglycerides, and pelvic lymph node status were shown to be independent prognostic factors for overall survival (p<0.05 for all). Furthermore, the results of the Kaplan-Meier survival curves showed that both the high total cholesterol group and the high triglycerides group were associated with worse overall survival (p=0.002 and p=0.001, respectively) CONCLUSIONS: Our study showed that total triglycerides and total cholesterol may serve as potential predictors for overall survival in patients with cervical cancer. Cervical cancer patients may benefit from treatments after adjusting their triglycerides and total cholesterol levels.
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Hipercolesterolemia/sangre , Triglicéridos/sangre , Neoplasias del Cuello Uterino/sangre , Adulto , Anciano , Anciano de 80 o más Años , Biomarcadores de Tumor/sangre , Femenino , Humanos , Hipercolesterolemia/tratamiento farmacológico , Estimación de Kaplan-Meier , Lipoproteínas HDL/sangre , Lipoproteínas LDL/sangre , Persona de Mediana Edad , Estadificación de Neoplasias , Periodo Preoperatorio , Estudios Retrospectivos , Neoplasias del Cuello Uterino/mortalidadRESUMEN
RESEARCH QUESTION: Intrauterine adhesions (IUA) are primarily caused by trauma to the endometrium, and hysteroscopy is presently the main treatment for IUA. However, high rates of post-operative adhesion re-formation remain a problem. In this study, the combination of an intrauterine device (IUD) with a Foley catheter and the balloon uterine stent were investigated to evaluate their efficacy in preventing adhesion re-formation and the subsequent reproductive outcomes in patients with moderate to severe adhesions. DESIGN: A prospective randomized controlled study was conducted in a university-affiliated hospital. A total of 171 women with Asherman's syndrome were initially recruited between August 2016 and December 2017 and were randomized to undergo either balloon uterine stent insertion or placement of a contraceptive IUD plus a Foley catheter after hysteroscopic adhesiolysis. Reduction of adhesion scores, incidence of adhesion re-formation, changes in menstrual flow and reproductive outcomes were analysed. RESULTS: A total of 118 participants were eligible for analysis. The American Fertility Society (AFS) scores were not significantly different between groups before hysteroscopic adhesiolysis. At the second-look hysteroscopy, the AFS scores and adhesion recurrence rates were significantly higher in the balloon uterine stent group compared with the combination group (P < 0.01 and P = 0.024, respectively). There were no statistically significant differences in pregnancy and live birth rates between the two groups. CONCLUSIONS: The combination of an IUD and a Foley balloon catheter had better efficacy in preventing adhesion re-formation than the balloon uterine stent alone; however, it did not produce better reproductive outcomes.
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Histeroscopía/efectos adversos , Enfermedades Uterinas/cirugía , Adulto , Femenino , Humanos , Estudios Prospectivos , Adherencias Tisulares/etiología , Adherencias Tisulares/prevención & control , Adherencias Tisulares/cirugía , Resultado del Tratamiento , Cateterismo Urinario , Enfermedades Uterinas/etiología , Enfermedades Uterinas/prevención & controlRESUMEN
OBJECTIVE: Nomograms are widely used as predictive tools to predict oncological outcomes intuitively and precisely. The aim of our study was to develop a nomogram for predicting overall survival (OS) of patients with early stage cervical cancer. METHODS: In this retrospective study, the clinical, pathological, and hematological data and prognosis of 795 cervical cancer patients were investigated. We identified and incorporated independent significant prognostic factors for OS to develop a nomogram. The predictive accuracy and discriminative ability were measured by concordance index. RESULTS: By univariable analysis and subsequent multivariable analysis, we identified body mass index, albumin, platelet, leukocyte, tumor differentiation, and the status of the pelvic lymph node (PLN) (all P < 0.05) as independent prognostic factors. The concordance index of the nomogram integrating these 6 variables was 0.74. The calibration curves for probability of 3- and 5-year OS also demonstrated ideal agreement between nomogram prediction and actual observation. CONCLUSIONS: We developed a novel nomogram that can provide prediction of OS for patients with early stage cervical cancer individually. Furthermore, studies are required to validate whether it can be applied to other cohorts.
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Nomogramas , Neoplasias del Cuello Uterino/mortalidad , China/epidemiología , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Estadificación de Neoplasias , Pronóstico , Estudios Retrospectivos , Riesgo , Tasa de Supervivencia , Neoplasias del Cuello Uterino/sangre , Neoplasias del Cuello Uterino/patologíaRESUMEN
BACKGROUND: Increased platelet has been identified as an independent and unfavorable prognostic indicator in various cancers including cervical cancer. In our study, the prognostic value of preoperative platelet count combining with FIGO (International Federation of Gynecology and Obstetrics) stage in patients with operable cervical cancer was investigated. METHODS: A large cohort study including 800 operable cervical cancer patients was conducted from May 2005 to December 2012. Cancer-related biomarkers such as platelet count, hematocrit, hemoglobin, RDW was evaluated together with FIGO staging system in stage IA1-IIA2 cervical cancer patients. The prediction validity of platelet together with FIGO stage was then evaluated by receiver operating characteristic (ROC) curve, and the areas under the curve (AUCs) were compared by Z test. RESULTS: Univariate cox proportional hazard analysis demonstrated that hematocrit, platelet count, hemoglobin, FIGO stage, tumor differentiation, PLN (pelvic lymph node metastasis), LVSI (vascular lymph node invasion) were associated with overall survival (OS) and disease free survival (DFS), instead of RDW (red cell distribution width), age and histological subtype. Multivariate analysis demonstrated that preoperative platelet and FIGO stage were independent predictors for OS and DFS in cervical cancer. Furthermore, significant improvements were found after the combination of platelet count and FIGO stage in predicting OS and DFS for cervical cancer patients (P=0.0128 and P=0.0385, respectively). CONCLUSIONS: Combination of platelet count and FIGO stage improved the prediction performance of FIGO staging and provide additional risk stratification for operable cervical cancer patients.
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Periodo Preoperatorio , Neoplasias del Cuello Uterino/sangre , Neoplasias del Cuello Uterino/diagnóstico , Femenino , Humanos , Persona de Mediana Edad , Estadificación de Neoplasias , Recuento de Plaquetas , Pronóstico , Neoplasias del Cuello Uterino/patología , Neoplasias del Cuello Uterino/cirugíaRESUMEN
Inflammation contributes to development and progression in a variety of cancers, including cervical cancer. We developed a novel cervical cancer systemic inflammation score (CCSIS) based on the preoperative platelet-to-lymphocyte ratio (PLR) and serum albumin levels. A retrospective analysis of clinical data from 795 patients with operable cervical cancer was then conducted to investigate the prognostic value of CCSIS and its association with the patients' clinicopathological features, overall survival (OS), and disease-free survival (DFS). CCSIS was predictive of OS and DFS. High CCSIS was correlated with more advanced FIGO stages, poor tumor differentiation, and the presence of PLN and LVSI. Both albumin levels and the PLR were independent prognostic indicators for operable cervical cancer. The use of the CCSIS could improve risk stratification and traditional clinicopathological analysis in cervical cancer.