Simple blood test may spot ovarian cancer sooner
NCT ID NCT00539162
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether combining the standard CA125 blood test with other tumor markers can help detect ovarian cancer earlier in women who are at low risk. Researchers will track 8,000 postmenopausal women over time, repeating blood tests and sometimes ultrasound if markers rise. The goal is to improve early detection, but this is an observational study, not a treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a simple blood test that catches ovarian cancer earlier, when it's easier to treat.
- What could go wrong
- This is an observational study, not a treatment trial. It may not prove that early detection saves lives, and false alarms could cause unnecessary worry or procedures.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 8,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2001
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 74 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Carol G. Simon Cancer Center / Atlantic Health
RECRUITINGMorristown, New Jersey, 07962, United States
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John Stoddard Cancer Center
RECRUITINGDes Moines, Iowa, 50309, United States
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Sylvester Comprehensive Cancer Center, Univ of Miami Miller School of Medicine
RECRUITINGMiami, Florida, 33136, United States
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The University of Texas at Austin
ACTIVE_NOT_RECRUITINGAustin, Texas, 78712, United States
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UT Health Science Center San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
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University of Minnesota
RECRUITINGMinneapolis, Minnesota, 55454, United States
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University of Oklahoma Health Sciences Center
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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University of Rochester Medical Center
RECRUITINGRochester, New York, 14642, United States
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University of Texas (UT) Southwestern Medical Center
ACTIVE_NOT_RECRUITINGDallas, Texas, 75390, United States
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University of Texas MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Women's Hospital of Texas, Obstetrics and Gynecology Associates (OGA)
RECRUITINGHouston, Texas, 77054, United States
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Women's and Infant's Hospital
RECRUITINGProvidence, Rhode Island, 02905, United States
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Other studies related to the condition(s) this trial covers.
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