A Comparison of the Cyclic Variation in Serum Levels of CA125 Across the Menstrual Cycle Using Two Commercial Assays
ABSTRACT Clinicians use CA125, a tumor-associated antigen, primarily to monitor epithelial ovarian cancer. However, CA125 lacks the sensitivity and specificity necessary for population-based screening in healthy women. The purpose of this study was to determine if serum concentrations of CA125 differed across the three phases of the menstrual cycle in healthy, premenopausal women using two commercially available assays.
Healthy, Caucasian women between the ages of 18 and 39 were enrolled using strict criteria to exclude factors known to contribute to CA125 fluctuations. Menstrual cycle regularity was determined using calendars maintained by participants for 3 months. After cycle regularity was established, blood was drawn at three time points for CA125 determination using two commercial assays (i.e., Siemens and Panomics).
Regardless of the assay used, CA125 values were highest during menses. The CA125 values decreased 0.2 U/ml per day from menses to the end of the same cycle, which resulted in a net decrease of 5.8 U/ml across the cycle.
The two commercial assays for CA125 determination demonstrated good concordance in terms of reference ranges regardless of epitope differences. While CA125 levels changed over the course of the menstrual cycle, these changes may not be clinically significant in healthy women. This study is the first to control for factors known to contribute to CA125 elevations; to quantify a decrease in CA125 levels across the menstrual cycle; and to confirm concordance in the relative decreases in serum CA125 levels across the menstrual cycle between two frequently used commercial assays.
- SourceAvailable from: Maria Grazia Porpora
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- "Cancer antigen 125 (CA125) is a tumor marker used for the differential diagnosis in a postmenopausal woman with an adnexal mass . However , in premenopausal age, CA125 is characterized by a low diagnostic specificity, as abnormally high concentrations can be found in malignancies of different origin including nonovarian gynecological cancer , in women with nongynecological diseases such as tuberculosis and liver cirrhosis, and also in pelvic inflammatory disease, uterine fibroids, or physiological conditions such as pregnancy or different phases of the menstrual cycle  . In patients with endometriosis, CA125 levels can be high. "
ABSTRACT: Background. Surgical excision of ovarian endometriomas in patients desiring pregnancy has recently been criticized because of the risk of damage to healthy ovarian tissue and consequent reduction of ovarian reserve. A correct diagnosis in cases not scheduled for surgery is therefore mandatory in order to avoid unexpected ovarian cancer misdiagnosis. Endometriosis is often associated with high levels of CA125. This marker is therefore not useful for discriminating ovarian endometrioma from ovarian malignancy. The aim of this study was to establish if the serum marker CA72-4 could be helpful in the differential diagnosis between ovarian endometriosis and epithelial ovarian cancer. Methods. Serums CA125 and CA72-4 were measured in 72 patients with ovarian endometriomas and 55 patients with ovarian cancer. Results. High CA125 concentrations were observed in patients with ovarian endometriosis and in those with ovarian cancer. A marked difference in CA72-4 values was observed between women with ovarian cancer (71.0%) and patients with endometriosis (13.8%) (P < 0.0001). Conclusions. This study suggests that CA72-4 determination can be useful to confirm the benign nature of ovarian endometriomas in women with high CA125 levels.Disease markers 09/2013; 35(5):331-5. DOI:10.1155/2013/984641 · 2.17 Impact Factor
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ABSTRACT: To evaluate the capacity to predict malignancy in women with adnexal tumors using CA 125 measurement and ultrasound criteria. This was a cross-sectional study including 103 women with a total of 110 adnexal tumors. CA 125 level was measured in a sample of peripheral blood. Lesions were classified by ultrasound, using standardized predetermined criteria, as benign (B) or malignant (M). Those that could not be classified by these criteria were assessed subjectively. Histopathologic examination of surgical specimens was used as the gold standard. Of 110 tumors, 79 (71.8%) were benign and 31 (28.2%) were malignant on histopathology. Ultrasound criteria could be applied to 91 (82.7%) tumors, resulting in a sensitivity of 90%, specificity of 87%, positive predictive value (PPV) of 69% and negative predictive value (NPV) of 97%. In tumors not classifiable according to ultrasound criteria, subjective sonographic assessment gave a sensitivity of 67%, specificity of 80%, PPV of 75% and NPV of 73%. At a cut-off point of 37.4 U/mL, CA 125 had a sensitivity of 69%, a specificity of 87.8%, a PPV of 69% and a NPV of 88% for detection of malignancy. When CA 125 was associated with age and ultrasound criteria in a logistic regression model, the sensitivity and specificity increased in the subset of sonographically malignant tumors. The majority of tumors were correctly classified using ultrasound criteria. CA 125 alone performed worse than did ultrasound in discriminating malignant from benign adnexal tumors. CA 125 measurement contributed to the diagnosis of malignancy, improving overall specificity, only in sonographically malignant tumors.Ultrasound in Obstetrics and Gynecology 09/2012; 40(3):360-6. DOI:10.1002/uog.11201 · 3.14 Impact Factor
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ABSTRACT: Background Endometriosis is frequently associated with high levels of CA125. This marker is therefore not useful for discriminating ovarian endometrioma from ovarian malignancy. The aim of this study was to establish a panel of complementary biomarkers that could be helpful in the differential diagnosis between ovarian endometriosis or other ovarian benign masses and ovarian cancer. Methods Blood samples from 50 healthy women, 17 patients with benign ovarian tumors, 57 patients with ovarian endometrioma and 39 patients with ovarian cancer were analyzed and serum values were measured for the following biomarkers: CA125, HE4 and CA72-4. Results Serum CA125 concentration was elevated in both patients with ovarian endometriosis and ovarian cancer but not in patients with other benign ovarian masses. HE4 was never increased in patients with endometriosis or benign masses whereas it was significantly higher in all patients with ovarian cancer (p < 0.05). A marked difference in CA72-4 values was observed between women with ovarian cancer (67%) and those with endometriosis (p < 0.05). Conclusions The results of the study suggest that HE4 and CA72-4 determination is the best approach to confirm the benign nature of ovarian endometrioma in women with high CA125 levels.Journal of Ovarian Research 07/2013; 6(44). DOI:10.1186/1757-2215-6-44 · 2.03 Impact Factor