PURPOSE: Tumor marker concentrations in a given specimen measured by different analyzers vary according to assay methods, epitopes for antibodies used, and reagent specificities. Although great effort in quality assessment has been instituted, discrepancies among results from different analyzers are still present. We evaluated the assay performance of the UniCel(TM) DxI 800 automated analyzer in measuring the alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), carbohydrate antigen (CA) 125, CA 15-3 and CA 19-9 tumor markers. MATERIALS AND METHODS: The linearity and precision performance of the five tumor marker assays were evaluated, and concentrations of the respective markers as measured by DxI were compared to those measured by other conventional analyzers (ADVIA Centaur(TM) and Vitros(TM) ECi) using 200 specimens collected from 100 healthy persons and 100 patients with respective cancers. RESULTS: The linear fits for all five tumor markers were statistically acceptable (F=4648 for AFP, F=15846 for CEA, F=6445 for CA 125, F=2285 for CA 15-3, F=7459 for CA 19-9; p<0.0001 for all). The imprecision of each tumor marker assay was less than 5% coefficient of variation, except for low and high concentrations of AFP. The results from UniCel(TM) DxI 800 were highly correlated with those from other analyzers. CONCLUSION: Our results demonstrate that UniCel(TM) DxI 800 has good linearity and precision performance for the tumor markers assayed in this study. However, there were discrepancies between assaying methods. Efforts to standardize tumor marker assays should be undertaken, and the redetermination of cut-off levels is necessary when developing methods of analyzing tumor markers.
CA-125 Antigen/blood ; CA-19-9 Antigen/blood ; Carcinoembryonic Antigen/blood ; Humans ; Immunoassay/*instrumentation/*methods ; Tumor Markers, Biological/*blood ; alpha-Fetoproteins/metabolism

OBJECTIVETo study the effect of Compound Ezhu Powder (CEP) on serum levels of CA125 and CA19-9, and the expression of cyclin D protein in endometriosis patients, thus providing theoretical evidence for clinical application of CEP.

METHODSTotally 69 all endometriosis patients underwent surgical treatment at Department of Gynecology and Obstetrics, Tianjin Nankai Hospital from January 2011 to January 2013 were randomly assigned to group A (35 cases) and group B (34 cases). Meanwhile, 30 patients with uterine fibroids who prepared for surgical treatment during the same period were recruited as the control group. Patients in group A took EZP 3 months before surgery. No treatment was given to patients in group B and the control group. The serum CA125 level and the expression of cyclin D in the ectopic endometrium and the eutopic endometrium were detected in the 3 groups before surgery.

RESULTSThe expression of cyclin D was higher in group A and group B than in the control group (P < 0.05). The serum levels of CA125 and CA19-9 were significantly lower in group A than in group B (P < 0.05). The expression of cyclin D in the ectopic endometrium was lower in group A than in group B, but with no statistical difference (P > 0.05). The expression of cyclin D in the eutopic endometrium was significantly lower in group A than in group B with statistical difference (P < 0.05). Meanwhile, the serum CA125 level was positively correlated with the serum CA19-9 level (r = 0.45, P < 0.05).

CONCLUSIONSThe expression of cyclin D obviously increased in endometriosis patients, which was associated with the occurrence of endometriosis. CEP could lower serum levels of CA125 and CA19-9, and down-regulate the expression level of cyclin D, indicating its roles in inhibiting the cell cycle.

Adult ; Antigens, Tumor-Associated, Carbohydrate ; blood ; CA-125 Antigen ; blood ; CA-19-9 Antigen ; blood ; Cyclin D1 ; metabolism ; Drugs, Chinese Herbal ; pharmacology ; Endometriosis ; blood ; drug therapy ; Female ; Humans

OBJECTIVETo investigate the tumor-associated antigen CA125 expression in the serum and cervical and vaginal secretions in women during normal reproductive period, and explore the clinical value of detecting tumor markers in the cervical and vaginal secretions.

METHODSA total of 145 women in reproductive period were divided into 3 age groups (20-29 years, 30-39 years, and over 40 years), and their CA125 levels in cervical secretion, vaginal secretion and serum were detected by automatic electro-chemiluminescent immunoassay.

RESULTSCA125 levels in the cervical secretion, vaginal secretion and serum showed no significant difference between the 3 age groups (P>0.05). In each group, CA125 levels differed significantly between the cervical secretion, vaginal secretion and serum (P<0.001). In the 145 women, the average CA125 level was 497.82 - or + 75.29 U/ml in the cervical secretion, 114.66 - or + 26.40 U/ml in vaginal secretion and 18.06 - or + 3.35 U/ml in serum, showing significant differences between them (P<0.001).

CONCLUSIONCA125 expression level is significantly higher in the cervical and vaginal secretions than in the serum in women in normal reproductive period, and its levels in cervical and vaginal secretions can be more sensitive and convenient for early detection of related diseases.

Adult ; Biomarkers ; analysis ; CA-125 Antigen ; blood ; metabolism ; Cervix Mucus ; metabolism ; Female ; Humans ; Middle Aged ; Vagina ; secretion ; Young Adult

OBJECTIVETo study the expression of P53 protein in the advanced ovarian serous adenocarcinoma and explore its potential correlation with the clinicopathological features and prognosis of ovarian cancer.

METHODSThe immunohistochemical staining was used to detect the expression of P53 protein in 183 patients with advanced ovarian serous adenocarcinoma. The correlation of P53 protein with the clinicopathological features and its significance in the assessment of prognosis were explored.

RESULTSThe P53 protein expression was positive in 62.8% of the patients. Chi-square test showed that the overexpression of P53 protein was positively correlated with the elevation of serum CA125 and the two-tier grading of ovarian serous adenocarcinoma (P<0.001, P=0.038). Univariate analysis suggested that the prognosis of patients was associated with two-tier grading (P=0.007), lymph node metastasis (P=0.036), preoperative serum CA125 level (P=0.002), and P53 overexpression (P<0.001). Multivariate analysis showed that the International Federation of Gynecology and Obstetrics stage (P=0.038), lymph node metastasis (P=0.002), and overexpression of P53 (P=0.001) were independent prognostic factors.

CONCLUSIONThe P53 protein expression is closely related to the prognosis of advanced ovarian serous adenocarcinoma and can be used as an important indicator for predicting the prognosis.

CA-125 Antigen ; blood ; Cystadenocarcinoma, Serous ; metabolism ; pathology ; Female ; Humans ; Lymphatic Metastasis ; Membrane Proteins ; blood ; Neoplasm Grading ; Neoplasm Staging ; Neoplasms, Glandular and Epithelial ; metabolism ; pathology ; Ovarian Neoplasms ; metabolism ; pathology ; Prognosis ; Tumor Suppressor Protein p53 ; metabolism

This study is a multi-center clinical study, which aimed to compare CA125, HE4, and risk of ovarian malignancy algorithm (ROMA) in predicting epithelial ovarian cancer of Korean women with a pelvic mass. Prospectively, serum from 90 Korean women with ovarian mass was obtained prior to surgery. For control group, serum from 79 normal populations without ovarian mass was also obtained. The HE4 and CA125 data were registered and evaluated separately and ROMA was calculated for each sample. Total 67 benign tumors and 23 ovarian cancers were evaluated. Median serum levels of HE4 and CA125, and ROMA score were significantly higher in patients with ovarian cancer than those with benign ovarian tumor and normal population (P < 0.001). In ROC curve analysis for women with a pelvic mass, area under the curve (AUC) for HE4 and ROMA was higher than CA125. Statistical differences in each study compared to CA125 were marginal (P compared to CA125; 0.082 for HE4 and 0.069 for ROMA). Sub-analysis revealed that AUC for HE4 and ROMA was higher than AUC for CA125 in post-menopausal women with a pelvic mass, but there were no statistically significant differences (P compared to CA125; 0.160 for HE4 and 0.127 for ROMA). Our data suggested that both HE4 and ROMA score showed better performance than CA125 for the detection of ovarian cancer in women with a pelvic mass. HE4 and ROMA can be a useful independent diagnostic marker for epithelial ovarian cancer in Korean women.
Algorithms ; Area Under Curve ; Biomarkers, Tumor/blood ; CA-125 Antigen/*blood ; Case-Control Studies ; Female ; Humans ; Middle Aged ; Neoplasms, Glandular and Epithelial/*blood/*diagnosis ; Ovarian Neoplasms/*blood/*diagnosis ; Predictive Value of Tests ; Prospective Studies ; Proteins/*metabolism ; ROC Curve ; Reference Values ; Republic of Korea

PURPOSE: To determine the most powerful cancer antigen 125 (CA125)-related prognostic factor for advanced epithelial ovarian cancer (EOC) and to identify cut-off values that distinguish patients with a poor prognosis from those with a good prognosis. MATERIALS AND METHODS: We included 223 patients who received staging laparotomy and were diagnosed with stage IIC-IV serous EOC. Cox regression analysis was used to determine the most significant prognostic factor among the following variables: serum CA125 before surgery and after the first, second, and sixth cycles of chemotherapy; the nadir CA125 value; the relative percentage change in CA125 levels after the first and second cycles of chemotherapy compared to baseline CA125; CA125 half-life; time to nadir; and time to normalization of the CA125 level. RESULTS: The CA125 level after the first chemotherapy cycle was the most significant independent prognostic factor for overall survival (OS). Time to normalization (p=0.028) and relative percentage change between CA125 levels at baseline and after the first chemotherapy cycle (p=0.021) were additional independent prognostic factors in terms of OS. The CA125 level after the first chemotherapy cycle (p=0.001) and time to normalization (p<0.001) were identified as independent prognostic factors for progression free survival (PFS). CONCLUSION: Among well-established CA125-related prognostic factors, serum CA125 levels after the first cycle of chemotherapy and time to normalization were the most significant prognostic factors for both OS and PFS.
Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents/*therapeutic use ; CA-125 Antigen/*blood/metabolism ; Disease-Free Survival ; Female ; Humans ; Middle Aged ; Neoplasm Staging ; Neoplasms, Glandular and Epithelial/*blood/*drug therapy/mortality ; Ovarian Neoplasms/*blood/*drug therapy/mortality ; Prognosis ; Regression Analysis

OBJECTIVETo explore the association between the erythrocyte sedimentation rate, serum C-reactive protein (CRP) and the risk of lung cancer.

METHODSOne hundred and three patients with newly diagnosed lung cancer and 85 homochronous hospitalized patients with chronic respiratory diseases (including chronic obstructive pulmonary disease, asthma, bronchiectasis and pulmonary fibrosis) were included in this study. ESR, serum levels of CRP, CEA, CA19-9 and CA125 were analyzed in the two groups before the initiation of any therapy after hospitalization. The association with clinicopathological characteristics of lung cancer and the risk of lung cancer were estimated by logistic regression.

RESULTSBoth the ESR and CRP levels were significantly higher in the lung cancer group, as compared with that in the chronic respiratory diseases group (P < 0.001). There was no significant association of ESR and CRP with lung cancer stage and type. Spearman correlation analysis showed a positive correlation between ESR and CRP (r = 0.56, P < 0.001), ESR and CA125 (r = 0.33, P < 0.001), and CRP and CA125 (r = 0.32, P < 0.001). The results of multivariate logistic analysis showed that the level of CRP was associated with an increased risk of lung cancer. Adjusting the confounding factors such as age, gender and smoking condition, the risk increased along with the elevation of CRP. Compared with the first quantile patients, the risk of the second quantile patients increased twice (OR: 2.46, 95%CI: 1.16 - 5.20), the risk of the third quantile patients increased ten-fold (OR: 10.52, 95%CI: 4.40 - 25.18).

CONCLUSIONThe level of CRP is associated with an increased risk of lung cancer. The results of this study suggest that early detection of CRP may have a potential predicting value for high risk group of lung cancer.

Adenocarcinoma ; blood ; metabolism ; Adult ; Aged ; Blood Sedimentation ; C-Reactive Protein ; metabolism ; CA-125 Antigen ; metabolism ; Carcinoembryonic Antigen ; metabolism ; Carcinoma, Squamous Cell ; blood ; metabolism ; Chronic Disease ; Female ; Humans ; Logistic Models ; Lung Diseases ; blood ; metabolism ; Lung Neoplasms ; blood ; metabolism ; Male ; Membrane Proteins ; metabolism ; Middle Aged ; Neoplasm Staging ; Risk Factors ; Small Cell Lung Carcinoma ; blood ; metabolism

A variety of biomarkers have been identified in recent prospective and retrospective reports as being potentially predictive of venous thromboembolis (VTE), particularly idiopathic deep venous thrombosis (IDVT). This study identified a serum tumor biomarker for early screening of IDVT. A total of 128 IDVT patients (54 females and 74 males; average age: 50.9±17.4 years) were included. Carcinoembryonic antigen (CEA), ferritin, β2-microglobulin, cancer antigen (CA) 125, CA 15-3, CA 19-9, squamous cell carcinoma antigen (SCC), alpha-fetoprotein (AFP), prostate specific antigen (PSA), free PSA (f-PSA), and beta-human chorionic gonadotropin (β-HCG) in patients with IDVT were detected. Malignancies were histo- or cytopathologically confirmed. Of the 128 IDVT patients, 16 (12.5%) were found to have malignancies. Serum CEA, CA 125, CA 15-3, and CA 19-9 were found to be helpful for detecting malignancies in IDVT patients. Our study revealed a positive association between these markers and tumors in IDVT patients. On the other hand, SCC and AFP were not sensitive enough to be markers for detecting tumors in patients with IDVT. No significant differences were found in positive rates of ferritin and β2-microglobulin between tumor and non-tumor groups, and no significant difference exists in serum levels of ferritin and β2-microglobulin between the two groups. Carbohydrate antigens, CA 15-3 in particular, may be useful for differential diagnosis and prediction of malignancies in patients with IDVT.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antigens, Neoplasm ; blood ; Antigens, Tumor-Associated, Carbohydrate ; blood ; Biomarkers, Tumor ; blood ; CA-125 Antigen ; blood ; CA-19-9 Antigen ; blood ; Carcinoembryonic Antigen ; blood ; Chorionic Gonadotropin, beta Subunit, Human ; Female ; Humans ; Male ; Middle Aged ; Mucin-1 ; blood ; Neoplasms ; blood ; complications ; diagnosis ; Prostate-Specific Antigen ; blood ; Retrospective Studies ; Sensitivity and Specificity ; Serpins ; blood ; Venous Thrombosis ; blood ; complications ; Young Adult ; alpha-Fetoproteins ; metabolism

OBJECTIVE: To investigate the clinical features,therapy and prognosis of patients with peripheral T cell lymphoma(PTCL), and to find out the prognostic factors of the disease. METHODS: The clinical data of 73 patients with PTCL were reviewed.The median pre-treatment disease course was 3 months.Fifty-five patients were males, and 18 were females, with the median age of 42 years.Five patients received the combined chemo-radio therapy, 65 received chemotherapy alone, and the other 3 patients were treated with auto hematopoietic stem cell transplantation (HSCT). RESULTS: Of all the patients, the overall 3 -year and 5-year survival rates were 38% (28 /73) and 22% ( 16 /73) respectively.The survival rates decreased with the progression of the Ann Arbor stages.The survival rate of the patients with B symptom (fever, night sweat, and weight loss) or the international prognostic factors index ( IPI)>2 was lower than those of the patients without B symptom or IPI<2.The patients with the increased CA125 or D-dimer lever had the worst curative effect. CONCLUSION Peripheral T cell lymphoma is highly aggressive with poor prognosis.The clinical features,Ann Arbor staging, IPI and B symptom are important prognostic factors.CA125 and D-dimer may be also important prognostic factors.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; CA-125 Antigen ; blood ; Female ; Fibrin Fibrinogen Degradation Products ; metabolism ; Humans ; Lymphoma, T-Cell, Peripheral ; diagnosis ; pathology ; therapy ; Male ; Middle Aged ; Prognosis ; Retrospective Studies ; Survival Rate

OBJECTIVETo investigate the clinical value of combination of human epididymis protein 4 (HE4), CA125 and the Risk of Ovarian Malignancy Algorithm (ROMA) in diagnosis of ovarian carcinoma.

METHODSTo detect the serum concentration of HE4 using ELISA and CA125 using ECL in patients of ovarian carcinoma group (n = 119), borderline ovarian tumor group (n = 36), benign ovarian neoplasm group (n = 96) and female healthy control group (n = 53). The ROMA based on the serum level of CA125, HE4 and a woman's menopausal status was used to calculate the predicted probability (PP) and diagnostic results of ovarian cancers.

RESULTSThe receiver operating characteristic (ROC) analysis showed the cut-off value was 67.3 pmol/L (the AUC was 0.906, the sensitivity was 80.7% and specificity was 94.6%). The serum levels of HE4 and CA125 in the ovarian carcinoma group were significantly higher than that in the borderline ovarian tumor group, benign ovarian neoplasm group and female healthy control group (P < 0.01). The serum levels of CA125 and HE4 showed statistically no significant difference between the borderline ovarian tumor group and benign ovarian neoplasm group (P > 0.05). The levels of HE4 and CA125 were reduced significantly in ovarian patients after surgery therapy (P < 0.01). The sensitivity and specificity of HE4 + CA125 combination was 92.7% and 72.5%. The ROMA that can classify patients into high and low risk groups was established as 9.3% in premenopausal and 27.3% in postmenopausal women.

CONCLUSIONSHE4 is a helpful biomarker for ovarian carcinoma diagnosis. Biomarker combination of HE4 and CA125, and applying of the ROMA are helpful to improve the accuracy in diagnosis of ovarian cancers.

Adenocarcinoma, Mucinous ; blood ; diagnosis ; surgery ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Biomarkers, Tumor ; blood ; CA-125 Antigen ; blood ; Cystadenocarcinoma, Serous ; blood ; diagnosis ; surgery ; Cystadenoma, Serous ; blood ; diagnosis ; surgery ; Endometriosis ; blood ; diagnosis ; Female ; Humans ; Menopause ; Middle Aged ; Ovarian Neoplasms ; blood ; diagnosis ; surgery ; Proteins ; metabolism ; ROC Curve ; Sensitivity and Specificity ; Teratoma ; blood ; diagnosis ; surgery ; Young Adult