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Use of CA125 and Complementary Biomarkers for the Early Detection of Ovarian Cancer in Low Risk Women

RecruitingHealthy volunteers welcome

Who can join

Ages 50 to 74 · Women · Healthy volunteers welcome

Full eligibility criteria
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 Criteria:

1. Female: Less than 50 years old or older than 75 years at the time of enrollment.
2. Psychiatric or psychological or other conditions which prevent a fully informed consent.
3. Prior removal of both ovaries.
4. Active non-ovarian malignancy.
5. 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.
6. 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.)
7. Hereditary Nonpolyposis Colorectal Cancer (HNPCC)/Lynch Syndrome: known genetic mutation, presumed HNPCC carrier, Amsterdam criteria.

About the study

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.

What is being tested

Sponsor: M.D. Anderson Cancer Center · Participants: 8,000 · Started: Jul 2, 2001

Contact the study team

Official record on ClinicalTrials.gov — NCT00539162

Locations in the U.S.

FloridaSylvester Comprehensive Cancer Center, Univ of Miami Miller School of Medicine, Miami
IowaJohn Stoddard Cancer Center, Des Moines
MinnesotaUniversity of Minnesota, Minneapolis
New JerseyCarol G. Simon Cancer Center / Atlantic Health, Morristown
New YorkUniversity of Rochester Medical Center, Rochester
OklahomaUniversity of Oklahoma Health Sciences Center, Oklahoma City
Rhode IslandWomen's and Infant's Hospital, Providence
TexasUniversity of Texas MD Anderson Cancer Center, Houston
Women's Hospital of Texas, Obstetrics and Gynecology Associates (OGA), Houston
UT Health Science Center San Antonio, San Antonio

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.