The study will be led by Johnathan M. Lancaster, M.D., Ph.D., a gynecologic oncologist, expert in personalized medicine and president of the Moffitt Medical Group, and funded through an unrestricted grant fromAustin-based Vermillion, Inc. It will feature two phases, the first phase will be retrospective, and will benchmark the care standards and variances provided to patients with ovarian, fallopian tube and/or primary peritoneal cancer. The second phase will model improvements in care quality and cost that may be afforded by creating a standardized triage algorithm employing different FDA-cleared or prototype multi-marker blood tests, along with established clinical diagnostic or prognostic factors such as pelvic exams and ultrasound imaging.
"It is imperative that we rapidly develop high-quality, cost-effective strategies for the diagnosis and treatment of ovarian cancer," said Dr. Lancaster. "Multiple studies have shown that patients with ovarian cancer who are treated from the beginning by a board-certified gynecologic oncologist have a better chance of beating the disease. Yet in the U.S., fewer than half of the patients with the disease receive care from a gynecologic oncologist. This likely contributes to the high death rate from the disease, and is simply unfair to patients. We have a duty to develop clinical management strategies that will change this pattern – to improve survival rates, quality of life, and the cost-effectiveness of care in our communities."
Nearly 22,000 women are diagnosed with ovarian cancer in the U.S. annually, and more than 14,000 die each year, making it the deadliest of all gynecologic cancers. Treatment advances during the last three decades have modestly improved the average length of survival following a diagnosis of ovarian cancer. Women diagnosed with ovarian cancer in 1975 had a five-year survival rate of 33.6 percent. Today, the rate is still only 44 percent.
"Today, on World Ovarian Cancer Day, we honor the thousands of women who have lost their lives to ovarian cancer, as well as the women, their families and care teams who are fighting this disease," said James LaFrance, chairman, president and chief executive officer of Vermillion. "Reducing the burden of ovarian cancer is central to our mission and to the health of women in the U.S. With the expertise of Dr. Lancaster and the Moffitt team, we believe this effort will facilitate an important dialogue and establish a path to improving ovarian cancer care and outcomes."
The study will measure the baseline triage effectiveness, treatment standards, early outcomes and cost of care for patients diagnosed with an adnexal malignancy. From this baseline, potential improvement in care and cost effectiveness will be calculated for different triage protocols, including molecular or proteomic biomarkers, such as the OVA1® blood test. OVA1 is an FDA-cleared, highly sensitive blood test that offers a way to predict whether a suspicious pelvic mass is malignant or benign, helping triage a woman to a gynecologic oncologist more quickly. OVA1 measures the levels of five tumor-secreted proteins (Beta-2 microglobulin, CA 125II, apolipoprotein A1, prealbumin and transferrin), while measuring the host response to ovarian cancer. Studies have shown that OVA1 improves the pre-surgical detection of ovarian cancer, regardless of stage or subtype, in patients with planned surgery for a suspicious mass.