News Release

UC Davis Medical Center begins enrolling women in study of blood test for ovarian cancer

Peer-Reviewed Publication

University of California - Davis Health

(SACRAMENTO, Calif.) - Ovarian cancer is sometimes called the silent killer because it is often undiagnosed until it has reached an advanced stage. Existing tests are too unreliable or too impractical to catch the disease early. Now researchers at the UC Davis Medical Center are studying a blood test they hope will detect the gynecological cancer at its earliest and more treatable stages.

Under the microscope in this 1,600-patient trial is an assay that detects elevated blood levels of lysophosphatidic acid (LPA), a lipid found in high quantities in the blood of ovarian cancer patients. Lysophosphatidic acids are naturally-occurring substances that stimulate cancer cell proliferation as well as the normal metabolic processes of intracellular calcium release, tyrosine phosphorylation and the activation of platelets during coagulation. Since LPA stimulates the growth of ovarian cancer cells, researchers believe that its presence in the blood may provide a reliable indicator of ovarian cancer.

"LPA is part of a class of chemicals called bioactive lipids that tell cells to grow," says Gary Leiserowitz, MD, chief of the division of gynecologic oncology at the UC Davis Medical Center and principal investigator for the trial. "This particular lipid seems to be a growth factor for ovarian cancer."

In an early research study, LPA appeared to be a better indicator of early-stage cancer than the existing tool, a test called CA125. CA125 test is used to monitor recurrence of ovarian cancer after treatment. However, CA125 is not elevated in about half the women with early stage disease. On the other hand, it can be elevated in women with benign conditions such as fibroid tumors, endometriosis (a condition in which the lining of the uterus clings to other organs in the pelvic region) or even pregnancy.

"Ovarian cancer is a stealth disease - often there are no symptoms until very late," says Leiserowitz. "A blood test that reliably detects malignancies at the onset of the disease is greatly needed."

This would be good news for people like Terri Gardella, 44, of Sacramento, Calif. Last year Gardella went to her family physician complaining of abdominal pain. Gardella, who had a history of endometriosis, underwent an ultrasound that revealed a suspicious mass. She asked her doctor to have a CA125 test performed.

"I had read on the Internet that it was a way to see if you had ovarian cancer, so I asked my doctor about it," Gardella recalls. "After all, it was just a blood test."

When her CA125 values came back five times the normal range, she was in shock. Convinced she had ovarian cancer, she made an appointment to see a gynecologic oncologist. The week-long wait until her doctor's visit was "a life-altering experience," Gardella says. "I couldn't sleep and was absolutely terrified." Gardella didn't know that endometriosis often makes CA125 levels rise. She was reassured when her gynecologic oncologist told her it was probably not cancer, but she didn't feel completely at ease until exploratory surgery revealed she had a benign cyst. Finally, she could relax.

"It was a lot to go through for basically nothing," she says.

Similarly, Linda Nelson was diagnosed with ovarian cancer earlier this year although she never had abnormal levels of CA125. During a routine gynecological exam, her family physician felt an unusual swelling on her abdomen. Nelson's ultrasound also showed a pelvic mass. The 55-year-old Sacramento resident had two CA125 tests that came back normal. Because of her other findings, she had surgery to remove what turned out to be early stage ovarian tumors. Prompt treatment and subsequent follow-up chemotherapy give Nelson an almost 95 percent chance of long-term remission. "I was very fortunate they caught my cancer because I had no symptoms," says Nelson. "Still, it would be nice to have had a better test than the CA125 to detect this cancer."

Early detection greatly improves a woman's chances of surviving this disease. Up to 90 percent of women diagnosed with localized ovarian cancer survive beyond five years. This rate drops to 30 percent in women whose cancer has spread beyond the ovaries. Unfortunately, nearly 75 percent of women are not diagnosed until their cancer has advanced to this stage.

Some 1,600 women are being sought for the nationwide study. UC Davis Medical Center, UC San Francisco and Cedars-Sinai Medical Center in Los Angeles are among three in the state and eight in the nation to participate in the trial. UC Davis Medical Center is the first to begin accruing patients.

Several categories of women are being sought for the trial, from women with no health problems to those already diagnosed with ovarian cancer.

Leiserowitz hopes that the LPA test can be used not only to detect cancer early but also to spare women from unnecessary exploratory surgery.

The assay was developed by Atairgin Technologies of Irvine, which intends to submit its application for approval to the FDA in early 2001. The trial is expected to be completed by the end of this year.

For information or to participate, call (800) 833-1193.

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Copies of all news releases from UC Davis Health System are available on the web at http://news.ucdmc.ucdavis.edu


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