Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk 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
|Study Start Date:||July 2001|
|Estimated Primary Completion Date:||July 2017 (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 if the disease has come back in women who have already had ovarian cancer. Tumor markers may be related to the status of the disease.
If you are eligible to take part in this research study, you will have blood (about 2-3 tablespoons) drawn every year while on study.
You will need to provide the name of a gynecologist or qualified healthcare professional willing to provide follow-up care, if needed.
Each time blood is drawn, the CA-125 analysis will be performed. If the CA-125 analysis shows that you are at a low risk of developing ovarian cancer, you will be asked to repeat the blood test in one year. If the CA-125 analysis shows that you are at a slightly higher risk, you will be asked to repeat the blood test in 3 months. If the CA-125 analysis shows that you are at an even higher risk, you will be asked to have a transvaginal ultrasound.
An ultrasound test uses sound waves to check the position, size, and shape of the ovaries. During a transvaginal ultrasound, a small probe will be placed in your vagina and used to create and measure sound waves. Based on the results of the transvaginal ultrasound, you and the study doctor will discuss options for further treatment or standard cancer management.
All study participants will be asked to complete a questionnaire. You will be contacted to collect follow-up information, and to make sure that you return for the follow-up blood draws. When you return for screening, your health status will be updated in your medical record before or at each visit, and any changes to your medical or cancer history will be noted. If you were not seen at a visit, the study staff will try to contact you by telephone or letter. Your medical information may also be updated using MD Anderson's Medical Informatics Section, or state tumor registries.
Your name or other identifying information will not be used at any time blood samples are drawn. Each sample will have an identifying number. Only the study coordinator will have the match between the identifying number and your identity.
Length of Participation:
Women will be enrolled on this study for up to 15 years, plus 1 year of follow-up. Your participation on this study may last up to 16 years.
This is an investigational study. Transvaginal ultrasound scans on this study are performed using FDA-approved and commercially available methods.
Up to 30,000 women will take part in this multicenter study. Up to 9500 will be enrolled at MD Anderson.
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 MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Karen H. Lu, MD|
|University of Texas Physicians-Family Practice Associates||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Karen H. Lu, MD||M.D. Anderson Cancer Center|