Purpose of this Study
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Key Points
- In 2004, it is estimated that more than 25,500 women in
the United States will develop-and more than 16,000 will
die-of ovarian cancer.
- The sooner ovarian cancer is found and treated, the better
are a woman's chances for recovery and long-term survival.
- This study will gather information to help determine the
answers to important questions about ovarian cancer.
- Currently, there is no effective approach to screening
for ovarian cancer.
- The study is also evaluating a new way of using the level
of CA-125 as a means of screening for ovarian cancer.
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NCI's Role and Goal
The National Cancer Institute is supporting and conducting research
on the detection and prevention of ovarian cancer. Research studies
called clinical trials are used by scientists to study better ways
to detect and prevent ovarian cancer. NCI's overall goal is to reduce
the incidence of ovarian cancer, and to diminish the pain and suffering
experienced by those women who do develop this illness.
Ovarian Cancer Incidence, Mortality, Detection,
and Risk
In 2004, it is estimated that more than 25,500 women in the United
States will develop ovarian cancer, and more than 16,000 will die
of this disease. The sooner ovarian cancer is found and treated,
the better are a woman's chances for recovery and long-term survival.
But ovarian cancer is hard to detect early. Many times, women with
ovarian cancer have no symptoms or just mild symptoms until the
disease is in an advanced stage. Women who are at increased genetic
risk of ovarian cancer are of particular concern, because their
lifetime risk of developing this cancer is so much higher than the
risk experienced by women in the general population.
Seeking the Answers to Important Questions
Although surgical removal of the ovaries
and the fallopian
tubes appears to greatly reduce the chance that high-risk
women will develop an ovarian cancer-like illness, there are still
many important questions, which need to be answered. These include:
- By how much does surgery reduce ovarian cancer risk?
- By how much does surgery reduce breast cancer risk?
- How does risk-reducing surgery affect quality of life for those
women who choose this approach?
- What factors influence a woman's decision about which of these
two management approaches to choose?
- How does premature (earlier-than-usual) menopause affect the
risk of developing the general medical problems that are more
common in postmenopausal women, such as osteoporosis and cardiovascular
disease?
- Are there detectable abnormalities in the ovaries of high-risk
women which might allow diagnosis at the earliest stages of the
malignant
process?
- How does the cancerous process actually occur at the cellular
and molecular levels in high-risk women?
A Different Approach to Ovarian Cancer Prevention Research
Most of the current information related to these questions is based
on studies that look back in time to evaluate high-risk women,
studied in highly-specialized cancer genetics clinics at major medical
centers. This type of information may be less accurate and less
applicable to the entire population of high-risk women than we would
prefer.
The Ovarian Cancer Prevention and Early Detection Study is a cohort
study that will collect data going forward in time (i.e.,
prospectively) from women seen at both large and smaller medical
centers across the U.S. It is hoped that this research approach
will produce information that is more precise, and more representative
of all high-risk women. Its emphasis on evaluating quality of life
and on collecting biological samples for future laboratory-based
research related to ovarian cancer are also special strengths of
the current study's design.
The Challenge: Detecting Ovarian Cancer
Before Symptoms Develop
Currently, there is no effective approach to screening
for ovarian cancer, either for women in the general population or
for high-risk women. Because the risk of ovarian cancer is so much
higher than normal in genetically at-risk women, they have been
selected as a population that is in particularly great need of an
effective ovarian cancer screening strategy.
Using CA-125 Levels
The Ovarian Cancer Prevention and Early Detection Study is evaluating
a new approach to using the level of CA-125,
a substance called a tumor
marker, which is often found in higher-than-normal amounts
in the blood of women with ovarian cancer, as a means of screening
for ovarian cancer. The new approach is based on looking at changes
in the levels of CA-125 over time as the basis for deciding
whether or not additional tests are needed to look for ovarian cancer.
This method uses a mathematical, computer-based tool known as "ROCA,"
the Risk of Ovarian Cancer Algorithm. This will be the first time
that the ROCA screening tool has been used in a clinical trial.
The important questions related to the screening portion of this
study include:
- Does ROCA hold promise as an improved ovarian cancer screening
strategy?
- How is ROCA affected by other characteristics of the women being
screened, such as age, prior pregnancy, and various medications?
- Are there new tumor markers (either proteomic or biochemical)
detectable in the blood samples that are being collected as part
of this study which might, either alone or in combination, be
more effective in detecting the presence of early ovarian cancer
than CA-125?
High Expectations
The Ovarian Cancer Prevention and Early Detection Study is expected
to produce very valuable information regarding these and other questions
of great importance to women who are at increased risk of ovarian
cancer. We cannot promise that taking part in this study will benefit
each of the women who join, but their participation is likely to
teach us a great deal about how familial ovarian cancer develops,
and help improve the management options that are available to future
high-risk women.
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