Use of CA125 and Complementary Biomarkers for the Early Detection of Ovarian Cancer in Low Risk Women
5 other identifiers
interventional
8,000
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable ovarian-cancer
Started Jul 2001
Longer than P75 for not_applicable ovarian-cancer
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 2, 2001
CompletedFirst Submitted
Initial submission to the registry
October 3, 2007
CompletedFirst Posted
Study publicly available on registry
October 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2028
May 6, 2026
April 1, 2026
27.4 years
October 3, 2007
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of increase in CA 125 levels and other tumor markers over time
\[Time Frame: Based on CA-125 level and other tumor markers, 3 options will result: 1) re-draw blood (CA-125 and other tumor markers) in 1 year, 2) re-draw blood (CA-125 and other tumor markers) in 3 months, or 3) re-draw blood (CA-125 and other tumor markers) and TVUS in 6 weeks +/- 2 weeks.\]
Based on CA-125 level, 3 options will result: 1) re-draw blood (CA-125) in 1 year, 2) re-draw blood (CA-125) in 3 months), or 3) re-draw blood (CA-125) AND TVUS in 6 weeks +/- 2 weeks.
Study Arms (1)
CA 125 Analysis
EXPERIMENTALExperimental: CA-125 Analysis Experimental: CA-125, HE4, and Osteopontin bio-marker analysis. Participants will have blood (3-4 tablespoons) drawn for CA-125 and other tumor markers. Depending on CA-125 level and other tumor markers: Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers in 1 year. Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers in 3 months, OR Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers, and a transvaginal ultrasound in 6 weeks +/- 2 weeks.
Interventions
Questionnaires completed at baseline and during each follow up visit.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
- Golfers Against Cancercollaborator
Study Sites (12)
Sylvester Comprehensive Cancer Center, Univ of Miami Miller School of Medicine
Miami, Florida, 33136, United States
John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
University of Minnesota
Minneapolis, Minnesota, 55454, United States
Carol G. Simon Cancer Center / Atlantic Health
Morristown, New Jersey, 07962, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Women's and Infant's Hospital
Providence, Rhode Island, 02905, United States
The University of Texas at Austin
Austin, Texas, 78712, United States
University of Texas (UT) Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Women's Hospital of Texas, Obstetrics and Gynecology Associates (OGA)
Houston, Texas, 77054, United States
UT Health Science Center San Antonio
San Antonio, Texas, 78229, United States
Related Publications (1)
Han CY, Lu KH, Corrigan G, Perez A, Kohring SD, Celestino J, Bedi D, Bedia E, Bevers T, Boruta D, Carlson M, Holman L, Leeds L, Mathews C, McCann G, Moore RG, Schlumbrecht M, Slomovitz B, Tobias D, Williams-Brown Y, Bevers MW, Liu J, Gornet TG, Handy BC, Lu Z, Bedia JS, Skates SJ, Bast RC Jr. Normal Risk Ovarian Screening Study: 21-Year Update. J Clin Oncol. 2024 Apr 1;42(10):1102-1109. doi: 10.1200/JCO.23.00141. Epub 2024 Jan 9.
PMID: 38194613DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Denise Nebgen, MD, PHD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2007
First Posted
October 4, 2007
Study Start
July 2, 2001
Primary Completion (Estimated)
November 30, 2028
Study Completion (Estimated)
November 30, 2028
Last Updated
May 6, 2026
Record last verified: 2026-04