Dataset Information

Diagnostic Added-Value of Serum CA-125 on the IOTA Simple Rules and Derivation of Practical Combined Prediction Models (IOTA SR X CA-125).

ABSTRACT: This study aimed to evaluate the diagnostic added-value of serum CA-125 to the International Ovarian Tumor Analysis (IOTA) Simple Rules in order to facilitate differentiation between malignant and benign ovarian tumors before surgery. A secondary analysis of a cross-sectional cohort of women scheduled for surgery in Maharaj Nakorn Chiang Mai Hospital between April 2010 and March 2018 was carried out. Demographic and clinical data were prospectively collected. Histopathologic diagnosis was used as the reference standard. Logistic regression was used for development of the model. Evaluation of the diagnostic added-value was based on the increment of the area under the receiver operating characteristic curve (AuROC). One hundred and forty-five women (30.3%) out of a total of 479 with adnexal masses had malignant ovarian tumors. The model that included information from the IOTA Simple Rules and serum CA-125 was significantly more superior to the model that used only information from the IOTA Simple Rules (AuROC 0.95 vs. 0.89, p < 0.001 for pre-menopause and AuROC 0.98 vs 0.83, p < 0.001 for post-menopause). The IOTA SR X CA-125 model showed high discriminative ability and is potentially useful as a decision tool for guiding patient referrals to oncologic specialists.

SUBMITTER: Phinyo P

PROVIDER: S-EPMC7912113 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Diagnostic Added-Value of Serum CA-125 on the IOTA Simple Rules and Derivation of Practical Combined Prediction Models (IOTA SR X CA-125).

Phinyo Phichayut P Patumanond Jayanton J Saenrungmuaeng Panprapha P Chirdchim Watcharin W Pipanmekaporn Tanyong T Tantraworasin Apichat A Tongsong Theera T Tantipalakorn Charuwan C

Diagnostics (Basel, Switzerland) 20210126 2

<h4>Background</h4>This study aimed to evaluate the diagnostic added-value of serum CA-125 to the International Ovarian Tumor Analysis (IOTA) Simple Rules in order to facilitate differentiation between malignant and benign ovarian tumors before surgery.<h4>Methods</h4>A secondary analysis of a cross-sectional cohort of women scheduled for surgery in Maharaj Nakorn Chiang Mai Hospital between April 2010 and March 2018 was carried out. Demographic and clinical data were prospectively collected. Hi ...[more]

PMID: 33530385

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Project description:ObjectiveOvarian cancer is the most deadly deadliest gynecological tumor in the female reproductive system. Therefore, the present study sought to determine the diagnostic performance of International Ovarian Tumor Analysis Simple Rules (IOTA SR), the Ovarian-Adnexal Reporting and Data System (O-RADS), and Cancer Antigen 125 (CA125) in discriminating benign and malignant ovarian tumors. The study also assessed whether a combination of the two ultrasound categories systems and CA125 can improve the diagnostic performance.MethodsA total of 453 patients diagnosed with ovarian tumors were retrospectively enrolled from Fujian Cancer Hospital between January 2017 and September 2020. The data collected from patients included age, maximum lesion diameter, location, histopathology, levels of CA125, and detailed ultrasound reports. Additionally, all ultrasound images were independently assessed by two ultrasound physicians with more than 5 years of experience in the field, according to the IOTA simple rules and O-RADS guidelines. Furthermore, the area under the curve (AUC), sensitivity, and specificity of the above mentioned predictors were calculated using the receiver operating characteristic curve.ResultsOut of the 453 patients, 184 had benign lesions, while 269 had malignant ovarian tumors. In addition, the AUCs of IOTA SR, O-RADS, and CA125 in the overall population were 0.831, 0.804, and 0.812, respectively, and the sensitivities of IOTA SR, O-RADS, and CA125 were 94.42, 94.42, and 80.30%, respectively. On the other hand, the AUCs of IOTA SR combined with CA125, O-RADS combined with CA125, and IOTA SR plus O-RADS combined with CA125 were 0.900, 0.891, and 0.909, respectively. The findings also showed that the AUCs of a combination of the three approaches were significantly higher than those of individual strategies (p<0.05) but not significantly higher than the AUC of a combination of two methods (p>0.05).ConclusionThe findings showed that a combination of IOTA SR or O-RADS in combination with CA125 may improve the ability to distinguish benign from malignant ovarian tumors.

Project description:BackgroundCA-125 is a clinical biomarker with predictive effect on the prognosis of different cancers. Numerous clinical trials have been conducted to investigate the possibility of using the pretreatment level of CA-125 to predict the prognosis of epithelial ovarian cancer (EOC). However, its value in predicting prognosis remains controversial. The purpose of this meta-analysis was to assess the predictive value of pretreatment CA-125 levels for prognosis in EOC patients.MethodsWe searched the EMBASE, Cochrane library, PubMed and Web of Science databases for studies published up to 3 December 2021, according to specific inclusion and exclusion criteria. The clinical studies that were included investigated the relationship between pretreatment CA-125 levels and ovarian cancer prognosis. Combined hazard ratios (HR) of overall survival (OS) and progression-free survival (PFS) reported in the studies were compared and analyzed using fixed-effects/random-effects models. Sensitivity analysis was used to assess study stability, while Egger's and Begg's tests were used to assess publication bias.ResultsThis meta-analysis included 23 studies published in 2004 - 2021 with a total of 10,594 EOC patients. Comprehensive analysis demonstrated that the serum level of CA-125 before treatment was significantly correlated with overall survival (OS: HR=1.62, 95%CI=1.270-2.060, p<0.001) and progression-free survival (PFS: HR=1.59, PFS: HR=1.59, 95%CI=1.44~1.76, p<0.001). After comparing data from different FIGO stages and treatments, we discovered that a high pre-treatment serum CA-125 level was associated with a low survival rate.ConclusionAccording to the results of this study, a higher pre-treatment serum CA-125 level is associated with poor survival outcomes, which can be utilized to predict the prognosis of EOC patients. Pre-treatment serum CA-125 level might provide reliable basis for predicting the risk of EOC disease progression. This study is registered with the International Prospective Register of Systematic Reviews (CRD42022300545).Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?RecordID=300545, identifier [CRD42022300545].

Project description:To evaluate the accuracy of subjective assessment (SA), the International Ovarian Tumor Analysis (IOTA) group Simple Rules Risk (SRR) and the Assessment of Different NEoplasias in the adneXa (ADNEX) model for the preoperative differentiation of adnexal masses in pregnant women. The study population comprised 36 pregnant women (median age: 28.5 years old, range: 20-42 years old) with a mean gestation age of 13.5 (range: 8-31) weeks at diagnosis. Tumors were prospectively classified by local sonographers as probably benign or probably malignant using SA. Final tumor histological diagnosis was used as the reference standard in all cases. Logistic regression SRR and ADNEX models were used to obtain a risk score for every case. Serum CA125 and human epidydimis protein 4 (HE4) concentrations were also retrieved and the Risk of Ovarian Malignancy Algorithm (ROMA) value was calculated. The calculated predictive values included positive and negative likelihood ratios of ultrasound and biochemical tests. Final histology confirmed 27 benign and 9 malignant (including 2 borderline) masses. The highest sensitivity (89%) and specificity (70%) were found for the subjective tumor assessment. Although no malignancy was classified as benign using the SRR criteria (sensitivity = 100%), the specificity of this scoring system was only 37%. At the cut-off risk level of >20%, the ADNEX model had a sensitivity of 78% and a specificity of 70%. Serum levels of CA125, HE4 and the ROMA risk model correctly identified adnexal malignant tumors with a sensitivity of 67%, 25% and 25%, respectively. Corresponding specificities were 72%, 100% and 100%, respectively. The highest positive and negative likelihood ratios were found for SA (LR+ = 3.0 and LR- = 0.16, respectively). Overall diagnostic accuracy of all predictive methods used in this study were similar (range: 70-75%) except for SRR (53%). Subjective assessment remains the best predictive method in complex adnexal masses found at prenatal ultrasound in pregnant women. For less experienced sonographers, both the SRR and ADNEX scoring systems may be also used for the characterization of such tumors, while serum tumor markers CA125 and HE4, along with the ROMA algorithm appear to be less accurate.

Project description:BackgroundTumor markers are established laboratory tools that help to diagnose, estimate prognosis, and monitor the course of cancer. For meaningful decision-making in patient care, it is essential that methods and analytical platforms demonstrate high sensitivity, specificity, precision, and comparability. Regular participation at external quality assessment (EQA) schemes is mandatory for laboratories. Here, a longitudinal evaluation of EQA data was performed to assess the performance of tumor marker assays over time.MethodsLongitudinal data of the cancer antigens (CA) 15-3 (n = 5,492), CA 19-9 (n = 6,802), and CA 125 (n = 5,362) from 14 INSTAND EQAs conducted between 2019 and 2023 were evaluated. A median of 197, 244 and 191 laboratories participated at the EQAs for CA 15-3, CA 19-9 and CA 125, respectively. Data evaluation encompasses intra- and inter-manufacturer specific variations over time, assay precision, and adherence to the EQA limits of ±24% for CA 15-3, ±27% for CA 19-9 and ±36% for CA 125.ResultsThe study showed median manufacturer-dependent differences of up to 107% for CA 15-3, 99% for CA 125, and even 549% for CA 19-9 between the highest and the lowest methods over the studied period. Regarding the normalized median of all methods, the values of the most deviant methods were 0.42 for CA 15-3, 7.61 for CA 19-9, and 1.82 for CA 125. Intra-manufacturer variability was generally low, with median coefficients of variation (CV) below 10%. As the methods were evaluated according to method-specific consensus values, most participants passed the EQAs within the acceptance criteria. When the criteria were consistently set at 24%, the central 90% of participants passed the EQAs in 78.6%-100% for CA 15-3 (with exception of AX), 89.3%-100% for CA 125, and 64.3%-100% for CA 19-9.ConclusionWhile intra-method precision of most analytical platforms is acceptable for all three tumor markers, considerable inter-method variability was observed over the whole studied period demonstrating the necessity for better standardization and harmonization of the methods, development of international reference materials, and comprehensive commutability studies with patient samples.

Dataset Information

Diagnostic Added-Value of Serum CA-125 on the IOTA Simple Rules and Derivation of Practical Combined Prediction Models (IOTA SR X CA-125).

Publications

Diagnostic Added-Value of Serum CA-125 on the IOTA Simple Rules and Derivation of Practical Combined Prediction Models (IOTA SR X CA-125).

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