Test ID: CA25    
Cancer Antigen 125 (CA 125), Serum

Evaluating patients' response to ovarian cancer therapy

Predicting recurrent ovarian cancer

This test is not useful for cancer detection screening in the normal population.

Cancer antigen 125 (CA 125) is a glycoprotein antigen normally expressed in tissues derived from coelomic epithelia (ovary, fallopian tube, peritoneum, pleura, pericardium, colon, kidney, stomach).

Serum CA 125 is elevated in approximately 80% of women with advanced epithelial ovarian cancer, but assay sensitivity is suboptimal in early disease stages. The average reported sensitivities are 50% for stage I and 90% for stage II or greater.

Elevated serum CA 125 levels have been reported in individuals with a variety of nonovarian malignancies including cervical, liver, pancreatic, lung, colon, stomach, biliary tract, uterine, fallopian tube, breast, and endometrial carcinomas.

Elevated serum CA 125 levels have been reported in individuals with a variety of benign conditions including: cirrhosis, hepatitis, endometriosis, first trimester pregnancy, ovarian cysts, and pelvic inflammatory disease. Elevated levels during the menstrual cycle also have been reported.

Males: Not applicable

Females: <46 U/mL

In monitoring studies, elevations of cancer antigen 125 (CA 125) above the reference interval after debulking surgery and chemotherapy indicate that residual disease is likely (>95% accuracy). However, normal levels do not rule-out recurrence.

A persistently rising CA 125 value suggests progressive malignant disease and poor therapeutic response.

Physiologic half-life of CA 125 is approximately 5 days.

In patients with advanced disease who have undergone cytoreductive surgery and are on chemotherapy, a prolonged half-life (>20 days) may be associated with a shortened disease-free survival.

Results cannot be interpreted as absolute evidence of the presence or absence of disease.

Serum markers are not specific for malignancy and values may vary by method. Values obtained with different assay methods cannot be used interchangeably.

Some individuals have antibodies to mouse protein (HAMA), which can cause interference in immunoassays that employ mouse antibodies. In particular, it has been reported that serum specimens from patients who have undergone therapeutic or diagnostic procedures that include infusion of mouse monoclonal antibodies may produce erroneous results in such assays. Rerunning the specimen in question after additional blocking treatment may resolve the issue.

No interference was observed from rheumatoid factors up to a concentration of 1200 IU/mL.

There is no high-dose hook effect at cancer antigen 125 (CA 125) concentrations of up to 50,000 U/mL.

1. Sturgeon CM, Duffy MJ, Stenman UH, et al: National Academy of Clinical Biochemistry laboratory medicine practice guidelines for use of tumor markers in testicular, prostate colorectal, breast, and ovarian cancers. Clin Chem 2008 Dec;54:11-79

2. Salani R, Backles FJ, Fung MFK, et al: Posttreatment surveillance and diagnosis of recurrence in women with gynecologic malignancies: Society of Gynecologic Oncologists recommendations. American Journal of Obstetrics and Gynecology 2011;204(6):466-478

3. The Role of the Obstetrician-Gynecologist in the Early Detection of Epithelial Ovarian Cancer. American College of Obstetricians and Gynecologists. 2011. Committee Opinion Number 477