Use of CA125 and Complementary Biomarkers for the Early Detection of Ovarian Cancer in Low Risk Women (NCT00539162)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (8 items).
Location: Sylvester Comprehensive Cancer Center, Univ of Miami Miller School of Medicine — Miami, Florida
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (12 Sites)
- Sylvester Comprehensive Cancer Center, Univ of Miami Miller School of Medicine — Miami, Florida
- John Stoddard Cancer Center — Des Moines, Iowa
- University of Minnesota — Minneapolis, Minnesota
- Carol G. Simon Cancer Center / Atlantic Health — Morristown, New Jersey
- University of Rochester Medical Center — Rochester, New York
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma
- Women's and Infant's Hospital — Providence, Rhode Island
- The University of Texas at Austin — Austin, Texas
- University of Texas (UT) Southwestern Medical Center — Dallas, Texas
- University of Texas MD Anderson Cancer Center — Houston, Texas
- Women's Hospital of Texas, Obstetrics and Gynecology Associates (OGA) — Houston, Texas
- UT Health Science Center San Antonio — San Antonio, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.