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In ovarian cancer, the absence of early symptoms and reliable screening methods results in nearly 80% of women being diagnosed after the disease has spread beyond the ovary. At this stage, the 5-year survival rate is 35%, but when ovarian cancer is detected earlier, the survival rate rises to 93%. Currently, the only standard methods available for detecting ovarian cancer are physical pelvic examinations by a physician, ultrasounds, or measuring blood levels for CA125. While more than 80% of women with advanced ovarian cancer have elevated levels of CA125 and an FDA-approved test is available for CA125 to monitor disease progression, the test does not always accurately detect the disease early.

A New Urine Test

My colleagues and I presented a study at the 2006 annual meeting of the American Association for Cancer Research on new research to develop a more reliable test to detect ovarian cancer. Other types of cancer have been detected by measuring various proteins in patients’ urine. As such, we researched enzymes and proteins involved in cell death, and discovered that Bcl-2—an anti-apoptotic protein in the urine—appears to be a potential indicator of ovarian cancer. At the University of South Florida, we conducted a pilot study testing urine samples from 90 women. After measuring samples in triplicate for Bcl-2 using ELISA assays, we found that women with ovarian cancer had levels of Bcl-2 that were at least 10 times higher than that of normal controls.

We also performed CA125 tests using ELISA kits. Sensitivity and specificity rates for elevated urinary Bcl-2 levels that were associated with ovarian cancer were almost 100%, while blood levels of CA125 correctly identified only 68% of ovarian cancer patients.

To further test the accuracy of Bcl-2 levels in detecting ovarian cancer, we compared levels of the anti-apoptotic protein in urine samples from seven ovarian cancer patients immediately before and within 2 weeks after initial debulking surgery. Bcl-2 levels decreased up to 100% following surgical removal of the tumor. These data suggest that the tumor is the source of Bcl-2 elevations in the urine of patients with ovarian cancer. Quantification of urinary Bcl-2 by ELISA-based assays may provide a novel, safe, and economical method for the detection of ovarian cancer.

More Research in the Works

With support from a U.S. Army Department of Defense grant, we’re now testing an additional 1,000 urine samples to further assess the ability of elevated Bcl-2 levels to detect ovarian cancer to enhance the validity of our earlier data. In addition, the University of South Florida is partnering with GeoPharma, Inc., which licensed the worldwide patent rights to commercialize the Bcl-2 test we’re pioneering.

Once the new test is validated and available commercially, there is potential to screen women with it during annual check-ups because it’s easy to obtain the urine sample required; theoretically, there should be a high degree of compliance. Furthermore, ELISA-based tests are standardized protocols in many aspects of detecting cancer and other diseases, so the test will hopefully not be too costly or time consuming. Future research may demonstrate that this test can be used to monitor the presence of ovarian cancer throughout the course of the disease and to predict therapeutic and prognostic outcomes.

Patricia A. Kruk, PhD has indicated to Physician’s Weekly that she has or has had the following financial interest: grant/research aid from the U.S. Army Department of Defense Ovarian Cancer Research Program and a Marsha Rivkin Center for Ovarian Cancer Research Pilot grant.