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

Recruiting now · Not applicable

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT00539162

Run by

M.D. Anderson Cancer Center

People needed

8000

Starts

2001-07-02

Expected to finish

2028-11-30

Last updated by the study team

2026-05-06

Who can join

Age: 50 and older, up to 74. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• UT Health Science Center San Antonio — San Antonio, Texas, United States (enrolling)
• John Stoddard Cancer Center — Des Moines, Iowa, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Carol G. Simon Cancer Center / Atlantic Health — Morristown, New Jersey, United States (enrolling)
• University of Rochester Medical Center — Rochester, New York, United States (enrolling)
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (enrolling)
• Women's and Infant's Hospital — Providence, Rhode Island, United States (enrolling)
• Women's Hospital of Texas, Obstetrics and Gynecology Associates (OGA) — Houston, Texas, United States (enrolling)
• Sylvester Comprehensive Cancer Center, Univ of Miami Miller School of Medicine — Miami, Florida, United States (enrolling)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• The University of Texas at Austin — Austin, Texas, United States
• University of Texas (UT) Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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