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   Yale-New Haven Hospital, New Haven, Connecticut, USA HealthLINK: Cancer

July 22, 2005

News this month
Researchers discover blood test to detect ovarian cancer early

Researchers at Yale School of Medicine have discovered a new blood screening test that could help identify ovarian cancer in its early stages, long before symptoms arise. The findings of Yale researchers were reported in the May 10 issue of Proceedings of the National Academies of Sciences (PNAS).

New blood screening test will help identify ovarian cancer in its early stages, long before symptoms arise.

The silent killer
Epithelial ovarian cancer is the leading cause of gynecologic cancer deaths in the United States and three times more lethal than breast cancer. One reason it is so deadly is the fact that epithelial ovarian cancer is not usually diagnosed until it has reached an advanced stage. There is no early detection screening test, and so the disease has become known as the “silent killer.”

“Early diagnosis can help prolong or save lives, but clinicians currently have no sensitive screening method because the disease shows few symptoms,” said the study's lead author Gil Mor, MD, of the department of obstetrics, gynecology and reproductive sciences at Yale School of Medicine.

Proteins over- and underexpressed
Mor conducted the research with David Ward of the Nevada Cancer Institute. In the article, the authors wrote that “early diagnosis of epithelial ovarian cancer (EOC) would significantly decrease the morbidity and mortality from this disease but is difficult in the absence of physical symptoms.” Based on earlier research that suggested certain individual proteins might be good cancer biomarkers, the researchers developed and tested a new blood test for the early detection of ovarian cancer based on four proteins: leptin, prolactin, osteopontin and insulin-like growth factor-II.

If the levels of two or more of these biomarkers fall within a certain warning area, the test will predict ovarian cancer.

Researchers found that if the levels of two or more of these biomarkers in a patient fall within a certain warning area, the test will predict that she has ovarian cancer.

More than 200 ovarian cancer patients and healthy women were tested. The results showed that 95 percent of the women with ovarian cancer had the protein markers in their blood.

The new blood test relying on the combination of the four analytes was found to exhibit the following qualities:

  • 95 percent sensitivity
  • 95 percent positive predictive value (PPV)
  • 95 percent specificity
  • 94 percent negative predictive value (NPV)

These outcomes are a considerable improvement on the current methodology according to the study's authors. “In the present study, we describe development of a blood test, based on four biomarkers, that exhibits a high specificity and sensitivity. This test is able to differentiate healthy individuals from ovarian cancer patients with an overall sensitivity/specificity of 95 percent, including 26/27 patients with stage I and II epithelial ovarian cancer,” concluded the authors. “This test should improve our ability to accurately detect premalignant change or early stage ovarian cancer in asymptomatic women at increased risk for the development of ovarian cancer.”

Test should improve ability to detect early stage ovarian cancer in asymptomatic women at increased risk for ovarian cancer.

The researchers recommended that if the new blood test were to be used to screen high-risk individuals, the results should be confirmed by retesting and followed by additional evaluations such as a transvaginal ultrasound. They felt this approach would provide “a sufficiently low false-positive rate to justify subsequent laparoscopic surgery on individuals with detectable pelvic masses.”

Further tests needed
The markers used in this blood test may not be specific to epithelial ovarian cancer only. Limited preliminary studies on women with other cancers (breast and uterine)—using these markers—also exhibited positive results in contrast to normal individuals. Rigorous investigation of whether the same set of proteins can serve as potential biomarkers of cancers other than epithelial ovarian cancer is needed.

While the new test looks promising for those at increased risk for ovarian cancer, due to the relative rarity of the disease more research and refinement is needed in order for the test to be used in widespread screening among the general population. Such screening tests need to achieve a specificity level of 99.9 percent in order to avoid large numbers of women being screened and falsely identified as having ovarian cancer.

Researchers will be looking at the inclusion of other biomarkers that may improve the sensitivity and specificity of such tests.


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2005 Best Hospital--U.S. News Online

Yale-New Haven was recognized this year by U.S. News & World Report for its cancer services.
Peter E. Schwartz, MD photo.

Early detection can increase cure rate

Ovarian cancer is one of the most deadly types of cancer, partly because it’s usually not diagnosed until the advanced stages. We simply don’t have a way of detecting it early, so seven out of 10 women won’t be diagnosed until Stages III or IV.

“Doctors will someday be able to detect ovarian cancer early through a blood test.”

Ovarian cancer has few symptoms early on, causing it to be called “the disease that whispers.” An estimated 22,220 women will be diagnosed to have ovarian cancer this year. This discovery is great news for women because it means that doctors will someday be able to detect ovarian cancer early through a blood test.

This blood test showed the levels of protein markers (leptin, prolactin, osteopontin and insulin-like growth factor-II) in the blood in patients with ovarian cancer. In the case of ovarian cancer, two markers will increase, or be overexpressed in the blood, while two will decline, or be underexpressed. The study of proteins on the molecular and cellular level is called proteomics.

Test is very hopeful
We have great hope for this test because the study was so definitive. Two hundred women were tested—100 had ovarian cancer and 100 were healthy. Of the 100 women who had ovarian cancer, 99 showed the protein markers in their blood.

Earlier research on this topic was published in 2002, but that study stopped short of identifying the proteins, only determining that the pattern of proteins in the blood was different in women with ovarian cancer. The study couldn't identify what proteins in the blood were overexpressed and which were underexpressed in ovarian cancer.

“While the test is probably five years away from becoming readily available to women, this brings great hope for curing the disease.”

With that information in hand, Yale researchers set out to identify known proteins—proteins that doctors can actually measure in the blood—and were successful in this most recent study.

Early detection brings a cure
 While the test is probably five years away from becoming readily available to women, this brings great hope for curing the disease. When ovarian cancer is detected early, 70-95 percent of cases can be cured. We still have a lot of work to do on this blood test, but we're on the right road. We need to find an easier way to automate the test; right now it's cumbersome and time-consuming.

In the meantime, women need to protect themselves from reproductive cancers by being aware of the warning signs.

Risk factors and warning signs
Symptoms of ovarian cancer include:

  • Bloating and abdominal distention
  • Vaginal discomfort
  • Change in bowel habits
  • Pressure on the bladder

The incidence of ovarian cancer rapidly rises after menopause. There is also a hereditary component to ovarian cancer. Women with breast cancer associated with the BRCA1 and BRCA2 gene mutations are more at risk for ovarian cancer.

Women with a first-degree relative with ovarian cancer are also more at risk, and those with no children have an increased risk level. For example, a woman without children has a five times higher risk for ovarian cancer than a woman with five or more children. A woman with one or two children has twice the risk.

Women who have taken birth control pills for more than five years have a decreased risk, as their ovaries haven't been active as long. Fertility treatments also haven't been shown to increase a woman's chances for ovarian cancer.

Discovery to Cure
At Yale-New Haven Hospital, we're committed to helping women improve their outcomes. Yale Gynecologic Oncology has started a program called, “Discovery to Cure: Advancing the Prevention, Early Detection and Treatment of Women's Reproductive Cancers.”

The program offers the most advanced medical options to accurately detect ovarian and other reproductive cancers at their earliest stages. It focuses on screening and prevention, helping women to understand and manage their risk.

Other studies underway at Yale
Discovery to Cure is one of the leading initiatives in the country, specializing in ovarian, breast, cervical and uterine cancers. It has many clinical trials under way that evaluate new treatment options. They include:

  • An indepth evaluation of an agent that unblocks proteins vital to the destruction of cancer cells that can be used in combination with chemotherapy.
  • A study of COX2 inhibitors to determine the best way to sensitize cancer cells to chemotherapy with the least amount of toxicity to healthy cells.
  • An examination of the process of DNA synthesis of cancer cells in combination treatment.
  • Determination of antitumor effects of active components of Chinese herbs.
  • Early detection of cancer cell death in treated patients.

For more information about any of these initiatives, you can visit the Yale Gynecologic Oncology Web site.

Dr. Schwartz is chief of the section of gynecologic oncology, the John Slade Ely professor of obstetrics and gynecology and vice chair of the department of obstetrics, gynecology and reproductive sciences at Yale School of Medicine.


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