Trial Information

Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women

Currently, there are no effective tests to detect ovarian cancer at its earliest stage.
CA-125 is an FDA approved marker for detecting recurrence of disease in women who have
already had ovarian cancer.

Women who are at least 50 years old, who are post-menopausal, are eligible for this study.
Patients will have their blood drawn each year for the duration of the study. The amount of
blood drawn will be about 2 to 3 tablespoons.

Women will need to provide the name of a gynecologist or qualified healthcare professional
willing to provide follow up care if it is indicated.

Each time blood is drawn, the CA-125 analysis will be performed. If the CA-125 analysis
shows that patients are at low risk of developing ovarian cancer, they will be asked to
repeat the blood test in one year. If the CA-125 analysis shows that patients are at a
slightly higher risk, they will be asked to repeat the blood test in 3 months. If the
CA-125 analysis shows that patients are at an even higher risk, they will be asked to have a
transvaginal ultrasound.

An ultrasound test uses sound waves to evaluate the position, size, and shape of the
ovaries. During an ultrasound, a small probe will be used to generate and measure sound
waves. It will be placed in the vagina. Based on the results of the transvaginal
ultrasound, patients and their physician will discuss options for management. At this
point, standard clinical management ensues.

Patient's will be asked to complete a questionnaire. Patient's will be contacted to obtain
follow up information, and to ensure that they return for their blood draws. When patients
return for screening, their health status will be updated prior to, or at each visit. Any
changes to the participant's medical or cancer history will be obtained at that time.
Attempts will be made to contact patients by telephone or letter that are not seen during
visits. Updates to each participant's cancer history may also be obtained via M. D.
Anderson's medical informatics section, if an M. D. Anderson patient, or state tumor
registries.

Patients' names will not be used at any time. Each sample will have an identifying number.
Only the study coordinator will have the match between the identifying number and the
patient's name.

This is an investigational study. A total of 30,000 women will take part in this study.
Women will be enrolled in the study during Year 1 thru Year 15 of the study. An additional
year, Year 16, will be for follow-up. For example, a woman enrolled in the beginning of
Year 1 will participate for sixteen years. A woman enrolled in the beginning of Year 2
will participate for fifteen years and a woman enrolled in the beginning of Year 3 will
participate for fourteen years and so on. Women will be enrolled at John Stoddard Cancer
Center, Des Moines, Iowa, Women's and Infant's Hospital in Providence, Rhode Island; The
University of Texas M.D. Anderson Cancer Center, Houston, Texas, UT Southwestern, Dallas,
Texas and Carol G. Simon Cancer Center, Morristown, New Jersey. In order to increase
community participation in Houston, Texas a free-standing physician practice, Obstetrics and
Gynecology Associates (OGA), has been been added.