Serum Human Epididymis Protein Research Articles

Comparative study of significance of serum human epididymis protein 4 (HE4) and carbohydrate antigen 125 (CA125) as an early tumour marker in female patients with ovarian cancer

Aim: To determine the usefulness of serum human epididymis protein4 (HE4) along with Carbohydrate Antigen 125 (CA125) as an early tumour marker in female patients with ovarian cancer.Method: The ovarian cancer patients were recruited from OPD/IPD of Surgery and Oncology department of SMS Hospital, and evaluated serum HE4 and CA125. Total 262 subjects were included in this study.131 ovarian cancer Patients were divided according to different stages and 131 control subjects also included.Results: Serum HE4 and CA125 level raised significantly in ovarian cancer patients. Further increases with the advanced stage of the ovarian cancer.Conclusion: Both HE4 and CA125 can be useful diagnostic tumour marker in ovarian cancer.

Prognostic and Diagnostic role of HE4 as a biomarker in ovarian cancer & comparison with CA125 in ovarian cancer patients with their menopausal status

Aim: to evaluate a new tumour marker HE4, in comparison with CA 125 and the Risk of Ovarian cancer in pre and postmenopausal women with ovarian cancer.Method: The ovarian cancer female patients were recruited from OPD/IPD of Surgery and Oncology department of SMS Hospital, and evaluated serum human epididymis protein (HE4) and CA125 Patients were divided into two group’s premenopausal and postmenopausal women with ovarian cancer.Results: Serum HE4 and CA125 level significantly high in postmenopausal women as compared to premenopausal women of ovarian cancer. The result was significantly high. (p

Can serum human epididymis protein 4 (HE4) support the decision to refer a patient with an ovarian mass to an oncology hospital?

IntroductionThe value of serum human epididymis protein 4 (HE4) in guiding referral decisions in patients with an ovarian mass remains unclear, because the majority of studies investigating HE4 were performed in oncology hospitals. However, the decision to refer is made at general hospitals with a low ovarian cancer prevalence. We assessed accuracies of HE4 in differentiating benign or borderline from malignant tumors in patients presenting with an ovarian mass at general hospitals. MethodPatients with an ovarian mass were prospectively included between 2017 and 2021 in nine general hospitals. HE4 and CA125 were preoperatively measured and the risk of malignancy index (RMI) was calculated. Histological diagnosis was the reference standard. ResultsWe included 316 patients, of whom 195 had a benign, 39 had a borderline and 82 had a malignant ovarian mass. HE4 had the highest AUC of 0.80 (95%CI 0.74–0.86), followed by RMI (0.71, 95%CI 0.64–0.78) and CA125 (0.69, 95%CI 0.62–0.75). Clinical setting significantly influenced biomarker performances. Applying age-dependent cut-off values for HE4 resulted in a better performance than one cut-off. Addition of HE4 to RMI resulted in a 32% decrease of unnecessary referred patients, while the number of correctly referred patients remained the same. ConclusionHE4 is superior to RMI in predicting malignancy in patients with an ovarian mass from general hospitals. The addition of HE4 to the RMI improved HE4 alone. Although, there is still room for improvement, HE4 can guide referral decisions in patients with an ovarian mass to an oncology hospital.

Serum Human Epididymis Protein 4 as a Prognostic Marker in Cervical Cancer.

ObjectivesThe objective is to evaluate the prognostic value of serum human epididymis protein 4 (HE4) as a tumor marker in patients with cervical cancer.Methods Sixty-seven patients with cervical cancer treated at Seoul National University Bundang Hospital from September 2014 to May 2018 were retrospectively reviewed. Serum HE4 levels were measured by immunoassay before starting primary treatment. A mean serum HE4 level of 72.6 pmol/L was used to divide the patients into low and high HE4 groups. Patient characteristics, clinicopathological variables, and survival outcomes were compared between the two groups.Results The low and high HE4 groups included 55 (82.1%) and 12 (17.9%) patients at diagnosis, respectively. Higher HE4 levels were significantly associated with older age at diagnosis (age <50: .0% vs age ≥50: 100.0%; P = .002), menopause (premenopause: 8.3% vs postmenopause: 91.7%; P = .009), higher FIGO stage (stage I–II: 33.3% vs III–IV: 66.7%; P = .017), large tumor size (<4.0 cm: 41.7% vs ≥4.0 cm: 58.3%; P = .029), positive lymph node metastasis (negative: 41.7% vs positive: 58.3%; P = .049), and involvement of the parametrium (negative: 25.0% vs positive: 75.0%; P = .002). Higher HE4 level was a predictive factor for worse overall survival but not for progression-free survival. Elevated HE4 levels were not independent factors for the prediction of either overall survival or progression-free survival. Subgroup analysis by histological type revealed similar results for patients with squamous cell carcinoma.ConclusionsHigh levels of HE4 expression correlated with poor overall survival, indicating that elevated HE4 levels are associated with a poor prognosis for patients with cervical cancer.

Prognostic Significance of Serum Human Epididymis Protein 4 Level in Patients with Locally Advanced Non-Small Cell Lung Cancer who Underwent Definitive Chemo-Radiotherapy

Prognostic Significance of Serum Human Epididymis Protein 4 Level in Patients with Locally Advanced Non-Small Cell Lung Cancer who Underwent Definitive Chemo-Radiotherapy

Application Value of Real-Time Ultrasonic Elastograph with Serum Human Epididymis Protein 4, Interleukin-33, and Carbohydrate Antigen 153 in Diagnosis of Early Cervical Cancer.

Objective To explore the application value of real-time ultrasonic elastograph (USE) with serum human epididymis protein 4 HE4, interleukin-33 (IL-33), and carbohydrate antigen 153 (CA153) in the diagnosis of early cervical cancer. Methods A total of 120 cervical cancer patients treated in our hospital (06, 2019–06, 2021) and meeting the study criteria were screened and divided into the benign group (BG, n = 70) and malignant group (MG, n = 50) according to their final diagnostic results, and healthy females who received physical examination in our hospital in the same period were selected as the control group (CG, n = 60). Patients in the three groups received real-time USE and detection of serum HE4, IL-33, and CA153 so as to analyze the diagnostic value of single examination and combined examination in diagnosing early cervical cancer. Results The patients' real-time USE score, Emax, Emean, and elastic fibers were significantly higher in the MG than those in the BG (P < 0.05), and the patients' real-time USE Emin, stroma ratio and collagen fibers were significantly lower in the MG than those in the BG (P < 0.05); the HE4, IL-33, and CA153 levels were obviously higher in the MG than those in the BG (P < 0.05) and were significantly higher in the BG than those in the CG (P < 0.05); the positive detection rate of combining real-time USE with serum HE4, IL-33, and CA153 was higher than that of single examination, and the diagnostic accuracy rate, sensitivity, specificity, positive predictive value, and negative predictive value of the combined examination were significantly higher than those of single examination (P < 0.05); according to the diagnostic efficacy of single examination and combined examination in diagnosing early cervical cancer by ROC curve, it was combined diagnosis > real-time USE > HE4 > CA153 > IL-33. Conclusion Combined examination of real-time USE and serum HE4, IL-33, and CA153 has higher diagnostic value in diagnosing early cervical cancer, which can obviously improve the diagnostic accuracy rate of cervical cancer.

Elevated Serum HE4 Concentrations and Risk of Cardiac Complications among Hospitalized Patients with Burns.

The decrease in effective blood volume after burns is closely related to abnormal heart function. To investigate whether serum human epididymis protein 4 (HE4), an indicator of early renal injury, contributes to increased risk of cardiac complications in patients with burns. Within 24 hours after hospital admission, clinical condition assessment and biochemical testing in patients with burns were performed. Multivariate analysis was performed by evaluating the relationship between serum HE4 levels and risk of cardiac complications (cardiac insufficiency, arrhythmia, and myocardial infarction) during hospitalization. The number (percentage) of cardiac complications in all included patients with burns was 80 (15.6%). The results of sensitivity analysis suggest that elevated serum HE4 levels were related to higher risk of cardiac complications in patients with sepsis (OR = 2.1; 95% CI, 1.19-3.17; P <.001) and in patients without sepsis (OR = 2.29; 95% CI, 1.33-4.71l; P = .005), respectively, after adjustments for clinical confounding factors were made. Sepsis did not have a modification effect on the association between serum and cardiac complications among these patients. Also, the results of ROC curve analysis showed that serum HE4 levels have good predictive value for predicting cardiac complications in patients with burns (AUC = 0.708; 95% CI, 0.61-0.81; P <.001). In the current study, we identified that elevated HE4 levels contributed to increased risk of cardiac complications in the hospital in patients with burns. This novel finding suggests that burn patients with serum HE4 may provide the opportunity to predict cardiac complications before hospital admission.

A clinical study of serum human epididymis protein 4 (HE4) in the diagnosis of pancreatic cancer.

Pancreatic cancer (PC) has poor early diagnosis rates due to its insidious onset. Since human epididymis protein 4 (HE4) is highly expressed in patients with PC, we assessed whether serum HE4 could be a marker for the detection 3 of PC. : Between May 2017 and October 2018, 127 patients with PC were recruited for the study along with 108 healthy controls who underwent health examinations. Serum HE4 concentrations were determined together with levels of carcinoembryonic antigen (CEA) and carbohydrate antigens (CA) 242 (CA242), CA19-9, CA15-3, and CA72-4 by electrochemiluminescence immunoassay (ECLIA) or chemiluminescence immunoassay (CLIA). Correlations between these biomarkers were assessed. : Serum levels of all six biomarkers were higher in patients with PC than in controls (P < 0.05). No correlation was observed between the serum levels of HE4 and the five other tumor markers, although there were strongly significant positive correlations between CA19-9 and CA15-3, and between CA242 and CA72-4. The lack of correlation indicates that HE4 has independent value in the diagnosis of PC. The combined assessment of serum HE4 levels and the other tumor markers improved the sensitivity of diagnosis. In particular, HE4 combined with CA19-9 performed significantly better than HE4 alone, or CA19-9 combined with the other markers. The HE4/CA19-9 combination resulted in 94.49% sensitivity and 99.07% specificity (95% confidence interval: 96.9-100). : HE4 is a biomarker associated with PC with a high specificity , either used alone, or evaluated with other biomarkers together improving the detection of PC. This study may provide a new clinical diagnostic approach for PC detection.

Serum HE4 and CA125 combined to predict and monitor recurrence of type II endometrial carcinoma

There is no recognized serum biomarker to predict the recurrence of endometrial carcinoma (EC). We aimed to explore serum human epididymis protein 4 (HE4) and cancer antigen 125 (CA125) as the biomarkers to predict and monitor recurrence of type II EC. 191 patients diagnosed with type II EC were involved for this retrospective study. Comparing recurrent with non-recurrent patients, HE4 levels resulted a statistically significant difference at primary diagnosis and recurrence, respectively (P = 0.002 and P = < 0.001), while CA125 levels resulted statistically significant (P = < 0.001) at recurrence. According to receiver operating characteristic curve analysis, the areas under the curve were significant for HE4 levels at primary diagnosis and recurrence predicting recurrence. Furthermore, CA125 levels at recurrence were significant. And the combination of both markers showed the higher sensitivity and specificity than single one. Patients with higher HE4 levels were associated with worse disease-free survival and overall survival, the opposite was true for patients with lower HE4 levels. The preoperative HE4 levels could be used to evaluate the risk factors of type II EC. Which suggested that HE4 levels might associated with the prognosis of type II EC. And combination of HE4 and CA125 could be applied to monitor recurrence during follow-up.

Serum Human Epididymis Protein 4 as a Novel Biomarker in Identifying Patients With Interstitial Lung Disease in Rheumatoid Arthritis.

Objective: Human epididymis protein 4 (HE4) have been implicated in the pulmonary involvements. We aimed to investigate the clinical utility of HE4 in clinical stratification in patients with rheumatoid arthritis (RA).Methods: This study included a discovery cohort comprising 70 RA patients and 64 healthy controls (HCs), and a validation cohort comprising 98 RA patients and 75 HCs. Human epididymis protein 4 were determined by electrochemical luminescence analyzer.Results: The levels of HE4 were significantly elevated in patients with RA compared to HCs. The positive rates of HE4 in patients with RA and HCs were 50.0% and 0, respectively, in the discovery cohort and 53.1 and 1.3%, respectively, in the validation cohort. When RA patients were subgrouped according to HE4 status, HE4-positive group displayed higher prevalence of interstitial lung disease (ILD) compared to HE4-negative group (28.6 vs. 11.4% in discovery cohort and 57.7 vs. 8.7% in the validation cohort). A positive correlation between the levels of HE4 with the degree of lung impairment was identified. Receiver operating curve (ROC) analysis revealed an optimal cut-off value of 104.3 pmol/L in HE4 for distinguishing RA-ILD from RA-non ILD with the areas under the curve (AUC) of 0.790. Multivariate logistic regression analysis illustrated that high levels of HE4 independently identified patients with RA-ILD (OR, 9.080, p < 0.001).Conclusion: Our findings showed a novel role of HE4 in RA risk stratification, suggest that introducing HE4 to the current RA test panel may serve as an indicator in identifying RA patients for further RA-ILD workups, such as high-resolution computed tomography (HRCT).

Application and clinical significance of TCGA molecular classification in endometrial cancer

Objective: To explore the application and clinical significance of the cancer genome atlas (TCGA) molecular classification in endometrial cancer (EC). Methods: Sixty-six EC patients collected from December 2018 to March 2021 from Peking University People's Hospital were categorized into four subgroups based on TCGA molecular classification tested by next generation sequencing. The correlation among four molecular subgroups and the clinical-pathological features including prognosis were analyzed. Results: (1) Clinical and pathological features: median age at diagnosis was 56 years (range: 24-78 years). The cases were distributed as follows: 3 (5%) cases DNA polymerase epsilon (POLE) ultra-mutated, 11 (17%) cases high microsatellite instability (MSI-H) including 2 Lynch syndrome, 42 (64%) cases low copy-number (CN-L) and 10 (15%) cases high copy-number (CN-H). There were significant differences among four subtypes in the combination of other tumors, tumor family history, surgical method, International Federation of Gynecology and Obstetrics (FIGO, 2009) stage, depth of muscle invasion and lymph vascular space invasion (all P<0.05). The proportions of patients in CN-H subgroup with advanced FIGO stage (stage Ⅲ-Ⅳ), deep muscle invasion and positive lymph-vascular space invasion were significantly increased. There were no significant differences in age, menopausal status, body mass index, metabolic syndrome-related complications, preoperative serum CA125 and human epididymis protein 4 levels, tumor size, pathological grade (only endometrioid cancer), and lymph node metastasis among the 4 TCGA molecular types (all P>0.05). (2) Immuno-related molecular analysis: among 66 EC patients, 27 patients underwent immunohistochemical analysis of programmed cell death 1 ligand 1 (PD-L1) protein, and 28 patients underwent tumor mutation burden (TMB) detection. POLE and MSI-H subgroups contained TMB than those in CN-L and CN-H (P<0.05).(3) Prognosis: the median follow-up time was 10 months (range: 0-28 months). The progression-free survival rate of TCGA molecular types were 100% (POLE ultra-mutated), 100% (MSI-H), 98% (CN-L), and 80% (CN-H) respectively and had significant differences (P=0.034). The overall survival were 100% (POLE ultra-mutated), 100% (MSI-H), 98% (CN-L), and 90% (CN-H) respectively, but there were not statistically significant difference (P=0.361). POLE ultra-mutated and MSI-H subgroups had the best survival, while CN-H had the worst. Conclusion: TCGA molecular classification has feasibility and clinical value in clinical application of EC, which is helpful to identify the prognosis of patients.

Serum Human Epididymis Protein 4 is a Potential Biomarker for Early Chronic Kidney Disease in an Obese Population [Retraction

[This retracts the article DOI: 10.2147/DMSO.S300940.].

The Prognostic Value of Biomarkers on Detecting Non-Small Cell Lung Cancer in a Chinese Elderly Population.

BackgroundSurvival in non-small cell lung cancer (NSCLC) remains poor. Early detection of NSCLC is of great significance to provide a chance to improve survival.AimWe constructed predictive models to evaluate the predictive value of four tumor biomarkers by including serum human epididymis protein 4 (HE4), carcinoembryonic antigen (CEA), squamous cell carcinoma antigen (SCCA), and cytokeratin 19 fragment (CY21-1) on detecting NSCLC in a Chinese elderly population.MethodsA total of 363 patients with NSCLC and 433 subjects without cancer (healthy control group) were admitted to the respiratory department in our hospital. We assessed serum levels of these four tumor biomarkers in the two groups and then the predictive value of predictive models was evaluated.ResultsSerum median values of HE4 (143.3 pmol/L), CEA (4.60 ng/mL), SCCA (1.52 ng/mL), and CY21-1 (5.36 ng/mL) in patients with NSCLC were significantly higher than the healthy control group, respectively (all P<0.05). A multivariate logistic regression model showed that HE4 (OR=2.10, 95% CI=1.22–4.42, P=0.013), CEA (OR=2.30, 95% CI=1.44–4.53, P=0.004), SCCA (OR=2.20, 95% CI=1.29–4.55, P=0.011), and CY21-1 (OR=2.60, 95% CI=1.56–6.25, P<0.001) were significantly and independently associated with increased risk of NSCLC on admission after confounding factors were corrected. Importantly, the ROC curve suggested HE4 had a good value on predicting NSCLC in the Chinese elderly population. Additionally, the predictive model (CEA+SCCA+CY21-1+HE4) had better idea capability to detecting the existence of NSCLC (AUC=0.954, 95% CI=0.927–0.999, P<0.001).ConclusionOur study showed that several lung cancer-related biomarkers were used to build prediction models, which has good value for early prediction of NSCLC.

Association Between Serum Human Epididymis Protein 4 Levels and Cardiovascular Events in Obese Patients with Breast Cancer.

BackgroundPatients with cancer have a higher incidence of cardiovascular diseases (CVDs). We aimed to evaluate the relationship between serum human epididymal protein 4 (HE4) levels and cardiovascular events in obese patients with breast cancer.MethodsSerum HE4 levels in 316 obese patients with breast cancer were measured at baseline and then prospectively followed up for approximately 36 months. The prognostic value of serum HE4 for predicting cardiovascular events was analyzed by the Cox proportional hazard model.ResultsSerum HE4 was significantly associated with CVD history after adjustment for confounding factors (OR= 1.50; 95% CI 1.23–3.43; P=0.038) using multivariable logistic regression analysis. The multivariable Cox proportional hazard analysis suggested that serum HE4 had an independent prognostic value for predicting cardiovascular events in patients with breast cancer (HR=2.21, 95% CI 1.60–5.13, P<0.001). Additionally, sensitivity analysis showed that the independent association still existed. Stratified analysis showed that this relationship was not affected by chemoradiotherapy.ConclusionSerum HE4 is significantly related to cardiovascular events and poses good prognostic value for predicting cardiovascular events in obese patients with breast cancer. Serum HE4 may be a valuable indicator for the early detection of cardiovascular complications in obese patients with breast cancer.

Comparison of Serum Human Epididymis Protein 4 (HE4) Levels in Breast Cancer Patients and Healthy Individuals

Comparison of Serum Human Epididymis Protein 4 (HE4) Levels in Breast Cancer Patients and Healthy Individuals

Serum Human Epididymal Protein 4 is Associated with Depressive Symptoms in Patients with Chronic Obstructive Pulmonary Disease [Retraction

[This retracts the article DOI: 10.2147/COPD.S282214.].

Elevated Serum Human Epididymis Protein 4 Is Associated With Disease Activity and Systemic Involvements in Primary Sjögren's Syndrome.

BackgroundWe aimed to investigate the clinical utility of human epididymis protein 4, a tumor biomarker being widely utilized in clinical practice in the diagnosis of ovarian cancer, in primary Sjögren’s Syndrome (pSS).MethodsA total of 109 pSS patients and 113 healthy controls (HCs) were included in the study. HE4 were determined by Roche Cobas E601 electrochemical luminescence analyzer. Clinical and laboratory findings were reviewed, and the relationships between HE4 and clinical parameters were determined by Spearman’s correlation test. The European league against rheumatism Sjögren’s syndrome disease activity index (ESSDAI) was utilized to evaluate disease activity.FindingsThe levels of HE4 were significantly elevated in patients with pSS compared to HCs (103.65 pmol/L vs. 46.52 pmol/L, p<0.001). The levels of HE4 were positively correlated with ESSDAI scores (r=0.462, p<0.001). Significant positive correlations between the levels of HE4 with pulmonary involvements (r=0.442, p<0.001) and renal involvements (r=0.320, p=0.001) were observed. Receiver operating curve (ROC) analysis revealed an optimal cut-off value of 104.90 pmol/L and 128.05 pmol/L for distinguishing patients with pulmonary and renal involvements, with the areas under the ROC curve (AUCs) of 0.778 (95%CI 0.685-0.870, p<0.001) and 0.768 (95%CI 0.646-0.891, p=0.001), respectively. Among patients with pulmonary involvement, the levels of HE4 were positively correlated with the semiquantitative HRCT grade (r=0.417, p=0.016), and negatively correlated with the percentage of forced vital capacity (FVC) (r= -0.460, p=0.047) and diffusing capacity of the lung for carbon monoxide (DLco) (r= -0.623, p=0.004). For patients with renal involvement, HE4 was positively correlated with creatinine (r=0.588, p=0.021) and negatively correlated with estimated glomerular filtration rate (r= -0.599, p=0.030).ConclusionsOur findings demonstrated a novel role of HE4 in clinical stratification of pSS, suggesting that introducing HE4 to the current pSS test panel may provide additional diagnostic value, particularly in evaluating disease activity and pulmonary/renal involvements.

Association of preoperative serum HE4 levels on the survival of patients with endometrial cancer.

To evaluate the association between preoperative serum human epididymis protein 4 (HE4) levels and survival outcomes in endometrial cancer (EC) patients. A retrospective cohort study was conducted of EC patients who were scheduled for surgery between September 2013 and May 2014 at Rajavithi Hospital. Association between preoperative serum HE4 levels and clinicopathological characteristics were evaluated. Cox proportional-hazards model was used to compare overall survival (OS) and recurrence-free survival (RFS) between EC patients who had high serum HE4 levels and those who did not. A total of 86 EC patients were enrolled. Serum HE4 levels was significantly associated with older age (p < 0.001), postmenopausal women (p = 0.001), large tumor size (p < 0.001), presence of lymphovascular invasion (p = 0.022), deep myometrial invasion (p = 0.001), lymph node metastasis (0.017), high-risk group (p < 0.001), and death status (p = 0.002). With a median follow-up of 53months, the 3-years OS and PFS of EC patients who had high serum HE4 levels were significantly poorer than those who did not (71% vs 95.8%, and 67.7% vs 91.7%, respectively). A high serum HE4 level was a significant prognostic factor for OS and RFS from the univariate analysis. However, it was not a significant prognostic factor in the multivariate analysis. Preoperative high serum HE4 levels were significantly associated with the worse clinicopathological characteristic of EC patients and decreased OS and RFS. Although there was no strong independent prognostic factor for survival, serum HE4 levels could be used in an algorithm for stratifying high-risk EC patients with more proper management.

Diagnostic value of serum human epididymis protein 4 and cancer antigen 125 in the patients with ovarian carcinoma: A protocol for systematic review and meta-analysis.

Background:Ovarian carcinoma (OC) is considered among the most prevalent triggers of cancer-related deaths in women. Many studies have demonstrated that human epididymis protein 4 (HE-4) as well as cancer antigen 125 (CA-125) are over-expressed in various malignant tumors, such as lung, liver, endometrial, gastric, breast, as well as ovarian cancers. Nonetheless, the overall diagnostic value of serum HE-4, in addition to CA-125 n patients experiencing OC, is still largely undetermined. Therefore, the current study intends to investigate the general diagnostic significance of HE-4 along with CA-125 in patients with OC.Methods:We aim to systematically search retrospective or prospective study for potential eligible studies from electronic databases, such as MEDLINE, EMBASE, Cochrane Library, Web of Science, as well as Chinese National Knowledge Infrastructure. We will relevant articles evaluating the general diagnostic significance of HE-4 and CA-125 in patients with OC from these databases. We will define our search in English and Chinese. Likewise, we will use 2 independent authors to extract the required data, using the Quality Assessment of Diagnostic Accuracy Studies-2 tool to evaluate he procedural quality of all included literature. We will use the appropriate statistical method to complete data analyses.Results:The present study aims to investigate the general diagnostic significance of HE-4 and CA-125 in patients suffering from OC.Conclusion:The present study will systematically summarise current evidence of HE-4 in combination with CA-125 in relation to diagnosing OC.Ethics and dissemination:Ethical approval will not be required.Protocol registration number:DOI 10.17605/OSF.IO/YQPC7 (https://osf.io/yqpc7/).

Copenhagen Index versus ROMA in preoperative ovarian malignancy risk stratification: Result from the first Vietnamese prospective cohort study

ObjectivesThis study aimed to evaluate the diagnostic performances of the Copenhagen Index (CPH-I) and Risk of Ovarian Malignancy Algorithm (ROMA) in the preoperative prediction of ovarian cancer. MethodsIn a prospective cohort study, data were collected from 475 patients with ovarian masses diagnosed by gynecologic examination / ultrasound who were hospitalized at the Departments of Obstetrics and Gynecology, Hue University of Medicine and Pharmacy Hospital and Hue Central Hospital, Vietnam, between January 2018 and June 2020. ROMA and CPH-I were calculated based on measurements of serum carbohydrate antigen (CA-125) and human epididymis protein (HE4). The final diagnosis was based on clinical features, radiologic and histologic findings, and the International Federation of Gynecology and Obstetrics (FIGO) 2014 stages of ovarian cancer were recorded. Matching the values of ROMA and CPH-I to postoperative histopathology reports resulted in the preoperative prediction values. ResultsAmong the 475 women, 408 had benign tumors, 5 had borderline tumors and 62 had malignant tumors. The two indices showed similar discriminatory performances with no significant differences (p > 0.05). At an optimal cut-off, the sensitivities/specificities of ROMA and CPH-I for ovarian cancer diagnosis were 74.2% and 91.8%, 87.1% and 78.5%, respectively. The optimal cut-off for CPH-I was 1.89%. The areas under the ROC curves (AUCs) of ROMA and CPH-I were 0.882 (95% CI: 0.849–0.909) and 0.898 (95% CI: 0.867–0.924), respectively. ConclusionsThe introduction of the Copenhagen Index to help stratify the malignancy risk of ovarian tumors, irrespective of menopausal status, might be applied as a simple alternative with a similar efficacy to ROMA in clinical practice.