Early Detection of Ovarian Cancer
The goal of this clinical research study is to evaluate a method involving a blood test, called CA-125, that may be helpful in the early detection of ovarian cancer in post-menopausal women.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women|
- Rate of increase in CA 125 levels over time [ Time Frame: Once a year (Initial CA 125 test followed by another in 3 months or 12 months depending on initial assessment) ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Yearly blood draw of 2 to 3 tablespoons, with CA-125 analysis performed each time. Urine specimen obtained at each UT MDACC visit.
|Study Start Date:||July 2001|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
CA 125 Analysis
Participants considered to be at low risk for ovarian cancer.
Completed during follow up visits.
Other Name: Survey
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539162
|Contact: Karen H. Lu, MD||713-563-4579|
|United States, Iowa|
|John Stoddard Cancer Center||Recruiting|
|Des Moines, Iowa, United States, 50309|
|United States, Rhode Island|
|Women's and Infant's Hospital||Recruiting|
|Providence, Rhode Island, United States, 02905|
|United States, Texas|
|Baylor -Sammons Breast Center||Recruiting|
|Dallas, Texas, United States, 75246|
|University of Texas Physicians-Family Practice Associates||Recruiting|
|Houston, Texas, United States, 77030|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Karen H. Lu, MD|
|Principal Investigator:||Karen H. Lu, MD||M.D. Anderson Cancer Center|