Use of CA125 and Complementary Biomarkers for the Early Detection of Ovarian Cancer in Low Risk Women
M.D. Anderson Cancer Center · with National Cancer Institute (NCI), Golfers Against Cancer · NCT00539162
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 50–74 · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 8000
- US sites recruiting
- 10
- Study start
- July 2, 2001
- Record last updated
- October 9, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Questionnaire
Conditions: Ovarian Cancer
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Female, >/= 50 years old or less than 75 years old.
- Postmenopausal (>/= 12 months amenorrhea).
- Have at least one ovary.
- Cancer-free and have not received any chemotherapy or radiation therapy for >/=12 months prior to enrolling on this study.
- Willingness to return for CA 125 blood tests annually or earlier if indicated.
- Willingness to return to undergo transvaginal ultrasound if indicated.
- Women need to provide the name of a gynecologist or qualified healthcare professional willing to provide appropriate follow-up care if indicated
Exclusion Criteria
- Female: Less than 50 years old or older than 75 years at the time of enrollment.
- Psychiatric or psychological or other conditions which prevent a fully informed consent.
- Prior removal of both ovaries.
- Active non-ovarian malignancy.
- Women who have a history of non-ovarian malignancy will be eligible if they have no persistent or recurrent disease and have not received treatment for >12 months. If they are on SERMS (i.e. tamoxifen or aromatase inhibitors) they will not be excluded. Women maybe undergoing or have had treatment \<12 months prior to study entry for basal cell carcinoma only.
- High risk for ovarian cancer due to familial predisposition as defined by the following: a. Known mutation in BRCA1 of BRCA2. b. Two 1st or 2nd degree relatives of same lineage who have: two ovarian cancers; one ovarian cancer \& one pre-menopausal breast cancer; two pre-menopausal breast cancers; one pre-menopausal \& one post-menopausal breast cancer. (These conditions can also be met using the patient and one 1st or 2nd degree female relative.) c. Ashkenazi Jewish descent with one 1st degree or two 2nd degree relatives with pre-menopausal breast or ovarian cancer or participant has had pre-menopausal breast cancer. d. 1st or 2nd degree male relative with breast cancer diagnosed at any age. (First degree relative defined as children, siblings and parents. Second degree relative defined as half-siblings, aunts, uncles, nieces, nephews, grandparents, and grandchildren.)
- Hereditary Nonpolyposis Colorectal Cancer (HNPCC)/Lynch Syndrome: known genetic mutation, presumed HNPCC carrier, Amsterdam criteria.
Recruiting US locations
Sylvester Comprehensive Cancer Center, Univ of Miami Miller School of Medicine
Miami, FL 33136
Site contact: Brian Slomovitz, MD
John Stoddard Cancer Center
Des Moines, IA 50309
University of Minnesota
Minneapolis, MN 55454
Site contact: Samantha Hoffman, MD
Carol G. Simon Cancer Center / Atlantic Health
Morristown, NJ 07962
University of Rochester Medical Center
Rochester, NY 14642
Site contact: Richard Moore, MD
University of Oklahoma Health Sciences Center
Oklahoma City, OK 73104
Site contact: Laura Holman, MD
Women's and Infant's Hospital
Providence, RI 02905
University of Texas MD Anderson Cancer Center
Houston, TX 77030
Site contact: Denise H. Nebgen, MD, PHD, MD, PHD
Women's Hospital of Texas, Obstetrics and Gynecology Associates (OGA)
Houston, TX 77054
UT Health Science Center San Antonio
San Antonio, TX 78229
Site contact: Georgia McCann, MD
Study contacts (from the official record)
- Gwen H. Corrigan · 713-563-1790 · gcorriga@mdanderson.org
- Study Coordinator MD Anderson · 713-563-6728
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