A Sylvester Comprehensive Cancer Center researcher is leading a new clinical study focusing on early detection of ovarian cancer in postmenopausal women.
“An effective screening or diagnostic test could potentially save the lives of thousands of women around the world,” said Brian Slomovitz, M.D., who is Co-Leader of Sylvester’s Gynecologic Cancers Site Disease Group and Director of the Division of Gynecologic Oncology at the University of Miami Miller School of Medicine.
Because there are no clear symptoms of ovarian cancer, the disease is rarely detected until it has reached an advanced stage, when the mortality rate is extremely high, according to Slomovitz.
“If ovarian cancer could be detected at an early stage before the malignant cells travel to other areas of the body, treatment would be far more effective and the survival rate would increase dramatically,” he said.
The clinical research study at Sylvester involves taking a new approach to testing for CA 125, a protein found in the blood that has been approved by the Food and Drug Administration (FDA) as a biomarker for detecting recurrent disease in women who have already had ovarian cancer. High levels of CA 125 typically indicate a greater risk, although an experienced specialist in ovarian cancer should interpret the results because many noncancerous conditions can also increase the CA 125 level, Slomovitz said.
“Instead of evaluating the results of one CA 125 blood test as normal or abnormal, our study looks at how the level of CA 125 changes over time, using the Risk of Ovarian Cancer Algorithm (ROCA),” Slomovitz said. “Taking a series of samples would allow researchers to see if CA 125 is rising, an early indicator of possible cancer.”
Sylvester is part of a multi-center research study, “Use of CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women,” being led by the University of Texas MD Anderson Cancer Center in Houston.
The CA 125 algorithm study is open to postmenopausal women between ages 50 and 74 who have at least one ovary, are cancer-free and meet other criteria. Women at high risk for ovarian cancer with the known BRCA1 or BRCA2 genetic mutation are not eligible to participate. Individuals interested in the trial should send an email to email@example.com.
The five-year study involves a baseline screening and regular follow-up evaluations.
“We expect about 90 percent of participants will have normal biomarker levels, and will come back for a 12-month follow-up,” Slomovitz said. Women with elevated levels of CA 125 will be monitored more frequently, and those at highest risk will be referred for immediate ultrasound diagnostic testing.
Sylvester was recently awarded a National Cancer Institute Early Detection Research Network grant for future studies of biomarkers, including CA 125.
“Ultimately, we hope that an effective early detection solution will reduce deaths due to ovarian cancer,” Slomovitz said.
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