The Predictive Value Of HE4,CA125 And ROMA In The Diagnosis Of Ovarian Malignancy

[Objective]To compare the levels of serum HE4(human epididymis protein 4)and CA125(carbohydrate antigen 125)in gynecological benign and malignant tumors.To compare the levels of serum HE4 and CA125 in different pathological types,pathological grade and pathological stage of ovarian malignant tumors.To analyse the effects of different clinical features such as ascites,D-dimer,age,menopausal status and body mass index(BMI)on the serum levels of HE4 and CA125.To evaluate the predictive value of serum HE4,CA125 and ROMA(Risk of Ovarian Malignancy Algorithm)in the diagnosis of ovarian malignancy.[Method]1.This research enrolled 370 patients with benign or malignant gynecological tumors treated in the First Affiliated Hospital of Nanjing Medical University from January 2016 to March 2017.Serun levels of HE4 and CA125 were measured by electrochemiluminescence.The statistical results of each group were expressed as median and quartile range M(P25,P75).The groups were eompared with nonparametric test.2.The predicted probabiliy of ovarian malignancy(PP)was calculated by ROMA method in 194 patients initially diagnosed as pelvic mass.Diagnosis is positive when detection result is higher than the reference value after comparing detection results with normal range of serum HE4 and CA125 which is 0-140 pmol/L and 0-35U/ml.The critical values of PP in premenopausal and postmenopausal patients were 11.4%and 29.9%,respectively.The sensitivity,specificity,positive predictive value and negative predictive value of each indicator in diagnosing ovarian malignancy were calculated,then the results were compared by y2 test.the ROC curves were drawn.The area under the curve(AUC)was calculated,then the AUCs were compared by Z test.[Results]1.The level of serum HE4 in patients with ovarian malignancy was 180.00 pmol/L,which was significantly higher than that in endometrial cancer group,cervical cancer group,ovarian borderline tumor group,CINI-? group(Intraperitoneal neoplasia?-?),uterine adenomyosis group,uterine leiomyoma group,ovarian endometriosis group and other ovarian benign tumors group(P<0.05).The level of serum CA125 in patients with ovarian malignancy was 236.1 U/L,which was significantly higher than that in other groups except ovarian borderline tumors group and uterine adenomyosis group(P<0.05).2.The level of serum HE4 in patients with epithelial ovarian cancer(EOC)was significantly higher than that in non-epithelial ovarian malignancy(P<0.05).There was no significant difference in level of serum CA125 between EOC and other types of ovarian malignancies(P<0.05).3.There was no significant difference in serum HE4 level and CA125 level in different pathological stages and pathological grades of EOC patients(P>0.05).The levels of serum HE4 and CA125 in EOC patients with positive ascites were significantly higher than those in patients without ascites(P=0.001;P<0.001).The levels of serum HE4 and CA125 in EOC patients with abnormal D-dimer were significantly higher than those in patients with normal D-dimer(P=0.009;P=0.003).There were no significant differences(P>0.05)in levels of serum HE4 and CA125 between EOC patients with different menopausal status,different ages(? 40 years or>40 years)or different BMI(normal,overweight and obese)4.The sensitivity of HE4,CA125 and ROMA in diagnosis of ovarian malignancy were 66%,85.11%and 78.72%respectively.The sensitivity of CA125 was significantly higher than that of HE4(P=0.031).There was no statistical difference between ROMA and HE4 or between ROMA and CA125(P>0.05).The specificity of three indicators was 100%,62.59%and 83.67%respectively.This result showed that the specificity of HE4 was significantly higher than that of CA125 or ROMA and the specificity of ROMA was higher than that of CA125(P<0.05).The positive predictive values of three methods were 100%,42.11%and 60.66%respectively,and the positive predictive value of HE4 was significantly higher than that of ROMA or CA125(P<0.05).Negative predictive value were 90.18%,92.93%,92.48%and there was no significant difference between the three(P>0,05).5.With reference to ovarian border tumors and benign tumors,the ROC curves of three indicators in diagnose of ovarian malignancy were drawn and every AUC was calculated.The results showed that the ROC-AUC of HE4,CA125 and ROMA was 0.878,0.820 and 0.903 respectively.Comparing of every two ROC-AUCs by Z test revealed that the ROC-AUC of ROMA was higher than that of CA125(P=0.006)and there was no significant difference between ROMA and HE4,HE4 and CA125(P>0.05).[Conclusion]1.The level of serum HE4 in patients with ovarian malignancies was significantly higher than that in other gynecological benign and malignant tumors,whose sensiticity was higher than that of CA125.2.The level of serum HE4 in EOC was significantly higher than that in non-epithelial ovarian malignancies,and correlated with ascites and D-dimer.The levels of serum HE4 and CA125 in patients with ascites and abnormal D-dimer were significantly higher than those in patients with negative performances.3.Three indicators were compared with all the pathological types of ovarian malignancy included.The specifieity and positive predictive value of HE4 were both 100%,which were better than those of CA125 and ROMA,but the sensitivity of HE4 was significantly lower than that of CA125.The predictive value of ROMA is better than single detecting CA125,but there is no significant difference in the predictive value of HE4 and CA125.