Researchers at Yale School of Medicine have developed a blood test with enough sensitivity and specificity to detect early stage ovarian cancer with 99 percent accuracy.
Results of this new study are published in the February 15 issue of the journal Clinical Cancer Research. The results build on work done by the same Yale group in 2005 showing 95 percent effectiveness of a blood test using four proteins.
"The ability to recognize almost 100 percent of new tumors will have a major impact on the high death rates of this cancer," said Mor. "We hope this test will become the standard of care for women having routine examinations."
Epithelial ovarian cancer is the leading cause of gynecologic cancer deaths in the United States and three times more lethal than breast cancer. It is usually not diagnosed until its advanced stages and has come to be known as the "silent killer."
This new phase II clinical trial led by Gil Mor, M.D., associate professor in the Department of Obstetrics, Gynecology & Reproductive Sciences at Yale, included 500 patients; 350 healthy controls and 150 ovarian cancer patients. Mor and colleagues validated the previous research and used a new platform called multiplex technology to simplify the test into one single reaction using very small amounts of serum from the blood. The new platform uses six protein biomarkers instead of four, increasing the specificity of the test from 95 to 99.4 percent. The team looked for the presence of specific proteins and quantified the concentration of those proteins in the blood.
The Early Detection Research Network (EDRN) of the National Cancer Institute (NCI) independently evaluated the results of the test.
"This is the most sensitive and specific test currently available," said Mor. "Previous tests recognized 15 to 20 percent of new tumors. Proteins from the tumors were the only biomarkers used to test for ovarian cancer. That is okay when you have big masses of tumors, but it is not applicable in very early phases of the tumor. Testing the proteins produced by the body in response to the presence of the tumor as well as the proteins the tumors produce, helped us to create a unique picture that can detect early ovarian cancer."
Mor and colleagues have begun a phase III evaluation in a multi-center clinical trial. In collaboration with EDRN/NCI and Laboratories Corporation of America (LabCorp), they are testing close to 2,000 patients.
The test is available at Yale through the Discovery to Cure program. Yale has licensed the test to three companies: Lab Corp in the United States, Teva in Israel and SurExam in China.
Citation: Clinical Cancer Research 14 (4) February 15, 2008
Source: Karen N. Peart
Yale University
http://www.yale.edu/
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Test Detects Ovarian Cancer With 99 Percent Accuracy
- By gpawelski
- Posted June 9, 2008 at 12:53 am · 8 replies
- In Newly diagnosed
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- By momanderson920
- Posted June 9, 2008 at 7:30 am
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Thanks for sharing this with us. Unless we have knowledge of these new options, oftentimes our doctors don't offer them. Thanks so much!
- By Elaine1935
- Posted June 9, 2008 at 8:43 am
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What makes this test different from the CA125 ovarian cancer blood test?
- By gpawelski
- Posted June 9, 2008 at 12:38 pm
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The CA125 test can be quite useful, but it is very important to use it appropriately. CA125 levels are for monitoring the effectiveness of treatment in women who "have already" been diagnosed with ovarian cancer. As treatment progresses, a drop in the CA125 level gives doctors fairly good evidence (but not absolute) that treatment is working. If the level doesn't drop, then the treatment can be changed to something more effective (this is called trial-and-error treatment).
The CA125 is less than optimal as a screening test because of the test's low "sensitivity" and "specificity." Sensitivity and specificity are terms that apply to test accuracy. The standard has always been the accuracy of a test. This is true for every single test used in cancer medicine, from estrogen receptors to panels of immunohistochemical stains to diagnose and classify tumor to Her2/neu, CA125, cell culture assays, MRI, CT and Pet Scans.
Tests must have reasonably high sensitivities and specificities in order to be considered good screening tests. The sensitivity of a test refers to the likelihood that it will be positive when the diseas is present. The CA125 test misses a significant number of early ovarian cancers, when the need to detect them makes a difference. And the test cannot detect all ovarian cancer cell types.
The low specificity of the CA125 test measures the likelihood that the test will be negative when the disease is absent. CA125 levels can be high in a number of benign and malignant conditions including endometriosis, pelvic inflammatory disease, fibroids, pancreatic conditions and breast, endometrial and other cancers. The discovery of an elevated CA125 can result in a wild goose chase that can lead to unnecessary tests, treatments and surgeries that can carry serious risks (the same goes for the PSA test for prostate cancer).
A negative test in an otherwise healthy, asymptomatic woman can lead to a false sense of comfort, since the test could simply be failing to detect an early cancer or a less-common cell type. In women who have a higher than average risk for ovarian cancer (due to family history or previous infertility treatments), who have abnormal ovarian findings on radiological scans, or who have an abnormal pelvic exam, the test may be helpful and warranted.
In women at high risk (which my wife was in 1996), the combination of CA125 level, pelvic ultrasound and a pelvic exam can help distinguish those who are in immediate danger from those who are most likely not. For the most part, my wife's medical oncologists at our local community hospital relied almost entirely on the CA125 tumor marker. The rate of false positives/negatives makes it inadequate for use by itself for screening of high-risk patients. It should be supplemented with transvaginal ultrasonography and a rectovaginal pelvic exam all done at the same time.
The researchers at Yale have developed a blood test with enough "sensitivity" and "specificity" to detect early stage ovarian cancer with 99 percent accuracy (that's good!).
- By zircons
- Posted June 9, 2008 at 12:48 pm
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I discussed this new Yale test with my gyn/onc when I was last there in March. At that time, she said it was too early to say anything about it. I will be seeing another of my oncologists this month and I will ask again. There are lots of false positives with the CA 125, but that was the only test we had.
- By treeshouse
- Posted June 9, 2008 at 1:07 pm
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Thank you! Whenever I see your posts I know I will learn about current medical info! I appreciate you passing on the info you come across.
- By PattyKey
- Posted June 10, 2008 at 7:59 am
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It's great to know there is another test out there. When I was first diagnosed nine years ago, my CA-125 was elevated. After initial surgery, my CA-125 never went above ten. When I had a recurrence five and a half years later, my CA-125 was right around eight. There was also another cancer screening blood test that was negative for the presence of cancer. Even my surgeon told me that any recurrence would show up in the blood work long before it would be spotted on a CT-scan. In my case that was ot so. It concerns me that women put too much emphasis on the CA-125, just like I did, and not follow through with CTs, physical exams, etcetera. The CA-125 just simply does not tell the whole story for some people. And even though my most recent CA-125 was a three, and I am very happy about that, I still get peace of mind when I have a CT-scan and get the all clear notice.
- By xericjean
- Posted June 11, 2008 at 12:11 pm
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I HAVE HAD THE TEST. I post a web site for our members in the Colorado Ovarian Cancer Alliance, and saw info about the test on Yale's web site. In March, I saw that they had opened their clinical trial of the Yale Early Detection Assay (YEDA) to "outsiders", and I called them and sent my serum in. They have since closed it because, I think, of the overwhelming response. Yale has licensed YEDA to Laboratory Corporation of America, and Lab Corp is set for an announcement this summer. You might check periodically with a Lab Corp near you. Yale wanted to keep the cost down, and was to bill me $45 (I haven't received it yet), and my best guess is that part of the agreement is to keep costs within reach of most women.
Here's what I got. I went through my primary care doctor, and the results are sent to her. You don't just walk into Lab Corp and get it; at least, that was my experience. The YEDA measures six biomarkers: leptin, prolactin, osteopontin, IGF-II, MIF, and CA-125. The problem with CA-125 alone is that (and I'm not a medical person) the tumor has to be somewhat large for CA-125 to show up in the bloodstream. The other five biomarkers measure the body's response to the presence of cancer much earlier than CA-125, and Yale says it can catch ovca in the eary stage rather than Stage III or IV. On the first page of the report, there is a place to record the result. Mine was N for Normal, and you can bet my blood pressure went waaay down! It could have been C= high risk (Presence of disease). It also says, "A probability of abnormality value of 0.8 or greater indicates a positive reading (possible presence of disease)." My probability of abnormality was 0.03! The second page consists of six graphs, each showing where my markers landed on a scale from abnormal to normal, so that I could see exactly where they were located.
BTW, I had Stage Ic in 2003, with a recurrence, also caught early, in 2006. I'm currently 18 months out from my last carbo/Taxol chemo. I have totally changed my diet (mostly veggies), I exercise most days of the week, and see an oncology nutritionist for supplements. I also took QiGong for that mind/body connection. If the nasty little aliens return, I will make it as inhospitable as possible!
I hope this helps. I'm so very excited about the YEDA, and agree with them when they say they'd like it to be an annual event for all women—you get the mammogram, you get the Pap smear, and you get the YEDA. Best wishes!
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