Comparison of serum CYFRA 21-1 and ROMA in distinguishing ovarian cancer from benign pelvic masses.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15565-e15565
Author(s):  
Zhong-Qian Li ◽  
Robert J Smalley ◽  
Curtis L Glover ◽  
Savitha Raju ◽  
Katherine Falcone ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Cohort Study ◽  
Single Point ◽  
Pelvic Mass ◽  
Cancer Biomarker ◽  
Ca 125 ◽  
Serum Samples ◽  
Gynecological Diseases ◽  
Benign Gynecological Diseases ◽  
Female Subjects

e15565 Background: CYFRA 21-1 is a known lung cancer biomarker. In subjects with ovarian cancer (OC) versus those with benign gynecological diseases, serum CYFRA 21-1 was reported sensitivities (SN) of 44% and 41% at specificity (SP) of 95% for OC detection using an ELISA assay by Hasholzner U (1994) and Tempfer C (1998), respectively. Nolen B (2010) reported a SN of 84.1% and 85.8% and a SP of 85% and 79.3% with a combination of CYFRA 21-1, CA 125 and HE4 using a multiplex bead-based immunoassay in a training and validation set, respectively. We carried out a cohort study to evaluate the serum CYFRA 21-1 as an ovarian cancer biomarker and compared it with ROMA (Risk of Ovarian Malignancy Algorithm), an FDA-cleared ovarian cancer algorithm. Methods: ARCHITECT CYFRA 21-1 assay was used to measure the levels of serum CYFRA 21-1. Single point serum samples from 170 female subjects with a pelvic mass were randomly selected from an archive cohort of female subjects. Among the 170 subjects, 47 had OC (42 with epithelial OC and 5 with low malignant potential tumor) and 123 with benign gynecological diseases. ROMA values were obtained with HE4 EIA and ARCHITECT CA 125 II. Results: For ARCHITECT CYFRA 21-1, the ROC-AUC, cut-off, SN, SP, PPV and NPV were 86%, 1.8 ng/mL, 70.2% (95% CI: 55.1% to 82.7%), 95.1% (95% CI: 89.7% to 98.2%), 84.6% and 89.3%, repectively. For ROMA algorithm, the ROC-AUC, cut-off, SN, SP, PPV and NPV were 92%, 2.44, 89.4% (95% CI: 76.9% to 96.5%), 84.6% (95% CI: 76.9% to 90.4%), 68.9% and 95.4%, repectively. Chi-square test showed an SN for ROMA was significantly higher than that of ARCHITECT CYFRA 21-1 (p < 0.05), and SP for ARCHITECT CYFRA 21-1 was significantly higher than that of ROMA (p < 0.01). Conclusions: In distinguishing OC from benign gynecological diseases, ROMA algorithm appears to be more sensitive than serum ARCHITECT CYFRA 21-1 (p < 0.05), and serum ARCHITECT CYFRA 21-1 appears to be more specific than (p < 0.01) in this cohort study.

Comparison of two multimarker serum tests for the prediction of ovarian cancer in women with a pelvic mass.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 5555-5555
Author(s):  
David G. Grenache ◽  
Zivjena Vucetic
Keyword(s):  
Ovarian Cancer ◽  
Roc Curve ◽  
Pelvic Mass ◽  
Benign Disease ◽  
Curve Analysis ◽  
Cancer Risk Assessment ◽  
Risk Scores ◽  
Ca 125 ◽  
Serum Samples ◽  
Roc Curve Analysis

5555 Background: Distinguishing between benign and malignant disease in women with a pelvic mass is difficult. OVA1 and ROMA are two multi-marker serum tests that are FDA-cleared to assess risk of malignancy in individuals with a pelvic mass. This study compared the accuracy of these tests for the prediction of ovarian cancer (OCa) in women with a pelvic mass. Methods: OVA1 and ROMA risk scores were determined in a subset of 146 serum samples obtained prospectively from pelvic mass patients. Patients were categorized by an initial cancer risk assessment (ICRA) performed by a physician and true cancer status determined surgically. 31 patients with malignancy (6 with a benign ICRA) and 115 patients with benign disease (25 with a malignant ICRA) were evaluated. Quest Diagnostics performed the OVA1 tests (CA-125, prealbumin, apolipoprotein A-1, β2-microglobulin, transferrin) and calculated and interpreted the risk score. ROMA tests (CA-125 and HE-4) were determined by automated immunoassay using an Abbott Architect analyzer. ROMA risk scores were calculated using published formulas and interpreted against cutpoints previously established for automated CA-125 and HE-4 performed by manual ELISA. Results: There were 70 pre- and 76 post-menopausal subjects. Of the 31 with malignancy, 26 had OCa (54% >stage II), 5 with an ICRA of benign. ROC curve analysis of the entire cohort produced an AUC of 0.88 (95% CI 0.80-0.95) and 0.93 (95% CI 0.87-0.99) for OVA1 and ROMA, respectively. OVA1 had a sensitivity of 0.97 and a specificity of 0.55. ROMA had a sensitivity of 0.84 and a specificity of 0.83. The sensitivity of OVA1 for OCa in the ICRA benign cohort (N = 5) was 0.80 and for ROMA was 0.40. The respective specificity for benign disease in this cohort (N=90) was 0.64 and 0.90. The sensitivity of ROMA for OCa increased to 0.60 with a slight decrease in specificity (0.87) when a cutpoint determined by ROC curve analysis was used. Conclusions: Overall, OVA1 and ROMA have similar performance characteristics. In women with an ICRA of benign, OVA1 was more sensitive among those who had OCa but ROMA was more specific among those who did not. The use of a ROMA cutpoint specific for the combination of automated CA-125 and HE-4 tests improved sensitivity.

Serum HE4 as a Useful Biomarker in Discriminating Ovarian Cancer From Benign Pelvic Disease

2012 ◽  
Vol 22 (6) ◽  
pp. 1000-1005 ◽  
Author(s):  
Hong Zheng ◽  
Yunong Gao
Keyword(s):  
Ovarian Cancer ◽  
Pelvic Inflammatory Disease ◽  
Inflammatory Disease ◽  
Area Under The Curve ◽  
Pelvic Mass ◽  
Secretory Protein ◽  
Ca 125 ◽  
Serum Samples ◽  
Ovarian Endometriosis ◽  
Premenopausal Patients

ObjectiveTo evaluate the role of the novel tumor marker human epididymal secretory protein E4 (HE4) in discriminating ovarian cancer from benign pelvic disease in patients with a pelvic mass.MethodsSerum samples from 131 patients with epithelial ovarian cancer (EOC) and 126 patients with various benign pelvic diseases were collected preoperatively and tested for cancer antigen (CA)125 and HE4 levels. Receiver operator characteristic curves were constructed, and the area under the curve (AUC) was compared between the markers.ResultsThe median CA125 and HE4 levels were significantly higher in the patients with EOC than in those with benign disease (P < 0.001). Using benign controls as the comparison group for all cases, the AUC for combined HE4 and CA125 (0.955) was significantly higher than that for HE4 (0.941) or CA125 alone (0.924; P < 0.05). A comparison of premenopausal benign controls to EOC cases showed that the AUC for combined HE4 and CA125 (0.97) was significantly higher than that for CA125 (0.93; P < 0.004). The AUC for HE4 was significantly higher compared to that of CA125 in discriminating EOC from ovarian endometriosis (0.969 vs 0.904; P = 0.014) and pelvic inflammatory disease (0.909 vs 0.819; P = 0.034).ConclusionSerum HE4 testing is a more powerful tool than CA125 assay to discriminate EOC from ovarian endometriosis and pelvic inflammatory disease. For patients with a pelvic mass, especially premenopausal patients, the serum concentration of HE4 adds valuable information to CA125 in identifying patients with EOC from those with benign pelvic disease.

scholarly journals Automated Assay of a Four-Protein Biomarker Panel for Improved Detection of Ovarian Cancer

Cancers ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 325
Author(s):  
Christopher Walker ◽  
Tuan-Minh Nguyen ◽  
Shlomit Jessel ◽  
Ayesha B. Alvero ◽  
Dan-Arin Silasi ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Early Detection ◽  
Predictive Value ◽  
Early Stage ◽  
Ca 125 ◽  
Healthy Controls ◽  
Classification Models ◽  
Serum Samples ◽  
Protein Biomarker ◽  
Biomarker Panel

Background: Mortality from ovarian cancer remains high due to the lack of methods for early detection. The difficulty lies in the low prevalence of the disease necessitating a significantly high specificity and positive-predictive value (PPV) to avoid unneeded and invasive intervention. Currently, cancer antigen- 125 (CA-125) is the most commonly used biomarker for the early detection of ovarian cancer. In this study we determine the value of combining macrophage migration inhibitory factor (MIF), osteopontin (OPN), and prolactin (PROL) with CA-125 in the detection of ovarian cancer serum samples from healthy controls. Materials and Methods: A total of 432 serum samples were included in this study. 153 samples were from ovarian cancer patients and 279 samples were from age-matched healthy controls. The four proteins were quantified using a fully automated, multi-analyte immunoassay. The serum samples were divided into training and testing datasets and analyzed using four classification models to calculate accuracy, sensitivity, specificity, PPV, negative predictive value (NPV), and area under the receiver operating characteristic curve (AUC). Results: The four-protein biomarker panel yielded an average accuracy of 91% compared to 85% using CA-125 alone across four classification models (p = 3.224 × 10−9). Further, in our cohort, the four-protein biomarker panel demonstrated a higher sensitivity (median of 76%), specificity (median of 98%), PPV (median of 91.5%), and NPV (median of 92%), compared to CA-125 alone. The performance of the four-protein biomarker remained better than CA-125 alone even in experiments comparing early stage (Stage I and Stage II) ovarian cancer to healthy controls. Conclusions: Combining MIF, OPN, PROL, and CA-125 can better differentiate ovarian cancer from healthy controls compared to CA-125 alone.

scholarly journals Analytical and clinical evaluation of an electrochemiluminescence immunoassay for the determination of CA 125

1998 ◽  
Vol 44 (12) ◽  
pp. 2530-2536 ◽  
Author(s):  
Huub E van Ingen ◽  
Daniel W Chan ◽  
Walter Hubl ◽  
Hayato Miyachi ◽  
Rafael Molina ◽  
...  
Keyword(s):  
Multicenter Trial ◽  
Ca 125 ◽  
Newly Diagnosed ◽  
Cutoff Value ◽  
Gynecological Diseases ◽  
Electrochemiluminescence Immunoassay ◽  
Benign Gynecological Diseases ◽  
International Multicenter ◽  
Apparently Healthy

Abstract The CA 125 II assay on the Elecsys® 2010 analyzer was evaluated in an international multicenter trial. Imprecision studies yielded within-run CVs of 0.8–3.3% and between-day CVs of 2.4–10.9%; CVs for total imprecision in the manufacturer’s laboratory were 2.4–7.8%. The linear range of the assay extended to at least 4500 kilounits/L (three decades). Interference from triglycerides (10.3 mmol/L), bilirubin (850 μmol/L), hemoglobin (1.1 mmol/L), anticoagulants (plasma), and several widely used drugs was undetectable. Method comparisons with five other CA 125 II assays showed good correlation but differences in standardization. A 95th percentile cutoff value of 35 kilounits/L was calculated from values measured in 593 apparently healthy (pre- and postmenopausal) women. In 95% of patients with benign gynecological diseases CA 125 was ≤190 kilounits/L; 63% of patients with newly diagnosed ovarian carcinoma had values &gt;190 kilounits/L. A comparison of CA 125 values obtained with the Elecsys test and with other common CA 125 tests in monitored patients being treated for ovarian cancer showed identical patterns. In conclusion, the Elecsys CA 125 II assay is linear over a broad range, yields precise and accurate results, is free from interferences, and compares well with other assays.

scholarly journals Comparison of seven immunoassays for the quantification of CA 125 antigen in serum

1998 ◽  
Vol 44 (7) ◽  
pp. 1417-1422 ◽  
Author(s):  
Elvira M Davelaar ◽  
Gerard J van Kamp ◽  
Rob A Verstraeten ◽  
Peter Kenemans
Keyword(s):  
Ovarian Cancer ◽  
Clinical Performance ◽  
Correlation Coefficients ◽  
Roc Curves ◽  
Ca 125 ◽  
Serum Samples ◽  
Pelvic Tumors ◽  
Value Range ◽  
Patient Groups ◽  
Ca 125 Antigen

Abstract Seven CA 125 immunoassays were compared for their clinical performance. CA 125 concentrations were determined in 289 serum samples obtained from women with benign pelvic tumors (samples from 98 patients) and patients with various cancers (samples from 111 patients). In the range of 0–1000 kilounits/L, all assays tested were linearly correlated, with correlation coefficients ranging from 0.89 to 0.99. In relation to the original Centocor CA 125 assay, there was an overall tendency to measure higher absolute values in the lower CA 125 value range. This was not seen in relation to the Centocor CA 125 II assay. ROC curves (benign vs pretreatment ovarian cancer patients) were nearly identical for all assays, and the areas under the ROC curves were not markedly different. We conclude that the CA 125 assays tested are strongly related to each other and are clinically reliable for the quantification of serum CA 125 and that none of the assays offers higher diagnostic accuracy or better discrimination between patient groups, especially not in the lower ranges.

OVX1 radioimmunoassay complements CA-125 for predicting the presence of residual ovarian carcinoma at second-look surgical surveillance procedures.

1993 ◽  
Vol 11 (8) ◽  
pp. 1506-1510 ◽  
Author(s):  
F J Xu ◽  
Y H Yu ◽  
L Daly ◽  
K DeSombre ◽  
L Anselmino ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Cancer Patients ◽  
Elevated Serum ◽  
Ca 125 ◽  
Serum Samples ◽  
Persistent Disease ◽  
Second Look ◽  
Normal Individuals ◽  
Positive Results ◽  
Apparently Healthy

PURPOSE At second-look surgical surveillance procedures, normal CA-125 levels can be associated with persistent disease in 50% to 60% of patients. A novel radioimmunoassay (RIA) has been evaluated for the ability to identify patients with persistent disease who have normal levels of CA-125. MATERIALS AND METHODS The OVX1 double-determinant assay used a murine monoclonal antibody to detect an epitope on a high-molecular weight mucin-like glycoprotein. RESULTS Apparently healthy individuals had serum OVX1 levels of 2.23 +/- 2.48 U/mL (mean +/- SD). Elevated serum OVX1 levels (> 7.2 U/mL) were found in 5% of 184 normal individuals and in 70% of 93 epithelial ovarian cancer patients with clinically evident disease. Among sera from these ovarian cancer patients, OVX1 was elevated in 68% of 76 samples with CA-125 levels more than 35 U/mL and in 76% of 17 samples with CA-125 levels less than 35 U/mL. In serum samples obtained at the time of positive second-look laparotomy, 59% of 41 patients with CA-125 levels less than 35 U/mL had elevated OVX1 antigen levels, whereas 41% of 22 patients with CA-125 levels more than 35 U/mL had elevated serum OVX1 levels. In patients with negative second-look laparotomies, false-positive results were eliminated by increasing the threshold of OVX1 to 10.5 U/mL. At this level, 32% of 41 patients with positive second-look operations had an elevated OVX1 level, despite a normal CA-125 level. When used in combination, CA-125 (> 35 U/mL) and OVX1 (> 10.5 U/mL) detected persistent disease in 56% of 63 patients with positive surveillance procedures, compared with 35% when CA-125 was used alone (P < .05). CONCLUSION An elevated OVX1 level can alert oncologists to the possibility that ovarian cancer has persisted, despite the return of CA-125 to a normal range.

Novel fluoroimmunoassay for ovarian cancer biomarker CA-125

2009 ◽  
Vol 393 (5) ◽  
pp. 1521-1523 ◽  
Author(s):  
Davin Sok ◽  
Lisa-Jo A. Clarizia ◽  
Leslie R. Farris ◽  
Melisenda J. McDonald
Keyword(s):  
Ovarian Cancer ◽  
Cancer Biomarker ◽  
Ca 125

scholarly journals One-Stop Clinic for Patients with Suspected Ovarian Cancer Pathway from a Retrospective Outcome Study

2020 ◽  
Author(s):  
Ayisha Adeeba Ashmore ◽  
C. Gnanachandran ◽  
I. Luqman ◽  
K. Horrocks
Keyword(s):  
Ovarian Cancer ◽  
Primary Care ◽  
Pelvic Mass ◽  
Initial Assessment ◽  
Ca 125 ◽  
Outcome Study ◽  
Ovarian Malignancy ◽  
Cancer Symptoms ◽  
Nice Guideline ◽  
One Stop

Abstract Background:Recent encouragement in early detection of cancer nationally has significantly increased the number of referrals made through the two-week wait suspected cancer pathway. In particular women with abdominal pain and bloating are frequently having their Ca-125 levels investigated for suspected ovarian cancer and this has led to a significant increase in referrals to the ovarian cancer service. We have conducted this study to help improve the efficiency in which these patients are investigated and to improve future pathways within the referral service. Methods:A retrospective observational outcome study. Data were collected from electronic documents of patients’ referrals, assessments, and clinical correspondences.The study was conducted in a tertiary gynaecology cancer centre with primary care direct referrals. The pelvic mass clinic was the clinic setup with consultation, scan and patient support was available. All patients referred by direct primary care for suspected ovarian cancer over two years with Ca-125 result. Data were collected and analysed from the pelvic mass clinic over 48 months, which was available through electronic documentation. Data included information on their consultation, ultrasound scan findings, any further intervention, surgery, and histological outcome of all patient who underwent biopsies or surgery.Results: Two hundred and eighty-six patients were referred from primary care where the NICE guideline, ‘two-week wait for ovarian cancer’, was applied. Two hundred and twenty-three patients were included in this analysis, who had a Ca-125 result reported at the time of their referral. Out of the 223 patients, 126 patients were discharged with or without a repeat Ca-125 after the initial assessment. Seventeen patients were diagnosed with cancer following the referral, but only 12 of them had a primary ovarian malignancy. Conclusion:Majority of the patients with Ca-125 of more than 35U/mL, who were referred through this pathway, did not have cancer. This message can be disseminated by primary care practitioners who may be able to reassure patients prior to their initial consultation with a gynaecologist. This review queries the future value of using Ca-125 as the basis for referrals from primary care referrals for suspected ovarian malignancy. Further studies are required to assess whether a higher Ca-125 cut off may be used as the basis of referrals for postmenopausal women. One-stop focused gynaecology ultrasound clinic (OSFGUC) where clinicians may assess patients with suspected ovarian cancer symptoms and perform ultrasound scans may be better for managing this patient population.

Performance of a biomarker panel to identify malignancy within a pelvic mass population

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5566-5566
Author(s):  
L. Chen ◽  
H. D. Homesley ◽  
D. R. Scribner ◽  
G. H. Cantuaria ◽  
Q. He ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Differential Diagnosis ◽  
Early Stage ◽  
Pelvic Mass ◽  
Stage Iv ◽  
Serum Levels ◽  
Borderline Tumor ◽  
Serum Samples ◽  
Early Stage Disease ◽  
Biomarker Analysis

5566 Background: We previously reported the performance of biomarker combinations that displayed utility in identifying ovarian cancer from normal sera and in monitoring for disease recurrence. In this study, we evaluated the performance of a subset of these markers in differentiating ovarian cancer from benign pelvic mass. Methods: Pre-operative serum samples were prospectively collected from 254 patients undergoing surgical evaluation for differential diagnosis of a pelvic mass. Pathology showed 76 cases of epithelial ovarian carcinoma (EOC), 17 borderline tumors, 11 other gynecologic cancers, and 150 benign masses. 18 (23.7%) of the EOC patients had stage I tumors; 6 (7.9%) stage II; 44 (57.9%) stage III; and 8 (10.5%) stage IV. Serum levels of CA125, HE4, glycodelin, SLPI, MMP7, and Plau-R were ascertained. Biomarker performance was evaluated by a logistic regression model and leave one out cross-validation analysis. All calculations compared the benign vs. EOC and borderline tumor populations. Results: Individual biomarker sensitivity ranged from 28% to 77% at 85% specificity. The combination of CA125, HE4 and glycodelin exhibited the highest overall performance in identifying malignancy from benign masses, demonstrating 80% sensitivity, 80% specificity in patients <55 years, and 89% sensitivity, 80% specificity in patients ≥55. Total cohort performance was 85% sensitivity and 80% specificity. Glycodelin identified 7/22 CA125 and HE4 double negative patients, 5/7 of these patients were early stage (borderline, I or II), while only adding 4/150 false positive cases. Conclusions: Biomarker analysis within this test cohort demonstrates potential clinical utility in the differential diagnosis of pelvic mass patients, especially for the detection of early stage disease. The addition of glycodelin improved the detection of early stage cancer in sera that were negative for both HE4 and CA125. [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document