Use of CA125 and Complementary Biomarkers for the Early Detection of Ovarian Cancer in Low Risk Women
M.D. Anderson Cancer Center
Summary
The goal of this clinical research study is to find out if combining a standard blood test (CA-125) that checks for ovarian cancer with other blood tests that check for related tumor markers may be helpful in the early detection of ovarian cancer in women who are at low risk. Tumor markers are substances in the blood that may be related to ovarian cancer.
Description
Up to 8,000 women will take part in this multicenter study. Currently, there is no effective screening to detect ovarian cancer at its earliest stage in low risk women. CA-125 is an FDA approved blood test that may show the presence of ovarian cancer. Researchers have found other blood tests that detect ovarian cancers that may be missed by CA125 testing. Results of blood tests are combined into a Risk of Ovarian Cancer-2 (ROCA2) score to decide whether you need to return for additional bloodwork and/or an ultrasound. If you are eligible to take part in this research study: You will have bl…
Eligibility
- Age range
- 50–74 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Female, \>/= 50 years old or less than 75 years old. 2. Postmenopausal (\>/= 12 months amenorrhea). 3. Have at least one ovary. 4. Cancer-free and have not received any chemotherapy or radiation therapy for \>/=12 months prior to enrolling on this study. 5. Willingness to return for CA 125 blood tests annually or earlier if indicated. 6. Willingness to return to undergo transvaginal ultrasound if indicated. 7. Women need to provide the name of a gynecologist or qualified healthcare professional willing to provide appropriate follow-up care if indicated Exclusion Criter…
Interventions
- BehavioralQuestionnaire
Questionnaires completed at baseline and during each follow up visit.
Locations (12)
- Sylvester Comprehensive Cancer Center, Univ of Miami Miller School of MedicineMiami, Florida
- John Stoddard Cancer CenterDes Moines, Iowa
- University of MinnesotaMinneapolis, Minnesota
- Carol G. Simon Cancer Center / Atlantic HealthMorristown, New Jersey
- University of Rochester Medical CenterRochester, New York
- University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma