Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women
NCT ID: NCT00539162
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
8000 participants
INTERVENTIONAL
2001-07-02
2028-11-30
Brief Summary
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Detailed Description
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If you are eligible to take part in this research study:
* You will have blood (about 3-4 tablespoons) drawn for testing CA-125 and other tumor markers that can detect ovarian cancer.
* You will be asked to complete a questionnaire about your medical and family history. It should take about 20-30 minutes to complete.
* You will be asked to complete a questionnaire about your symptoms. It should take about 10-15 minutes to complete.
Depending on your CA-125 level:
* You will have blood (about 3-4 tablespoons) drawn for testing CA-125 and other tumor markers in 1 year.
* You will have blood (about 3-4 tablespoons) drawn for testing CA-125 and other tumor markers in 3 months, OR
* You will have blood (about 3-4 tablespoons) drawn for testing CA-125 and other tumor markers, and you will have a transvaginal ultrasound (to look at your ovaries and fallopian tubes) in 6 weeks +/- 2 weeks.
An ultrasound test uses sound waves to check the position, size, and shape of the ovaries. During a transvaginal ultrasound, a small probe will be placed in your vagina and used to create and measure sound waves.
Based on the results of the transvaginal ultrasound (if you receive one):
* You and the study doctor will discuss options for further treatment or standard cancer management, OR
* You will have blood (about 3-4 tablespoons) drawn for testing CA-125 and other tumor markers in 3 months.
When you return for your next yearly visit:
* You will be asked to complete the questionnaire about your symptoms.
* You will be asked to complete a follow-up visit survey so that any updates to your personal and family medical history can be recorded. It should take about 10 minutes to complete.
Your blood draw results will be sent to you by letter or e-mail so that you will know when to return for a visit.
If you miss a visit, the study staff may try to contact you by telephone, e- mail, or letter. Visit reminders may also be sent to you by letter or e-mail.
If you are unable to return for visits after 3 years, you will be taken off study. You may continue to take part in this study unless you no longer qualify for the study or you no longer would like to take part in this study.
If you develop ovarian or non-ovarian cancer on this study, researchers will no longer collect blood draws, transvaginal ultrasounds, or questionnaires from you. However, the study team will continue to collect updates in your medical record. This includes slides that will be reviewed from cases of ovarian or non-ovarian cancer that are collected as part of your standard of care.
Length of Study:
You will continue to return for visits depending on the CA-125 level from your last visit. If you are unable to return for visits after 3 years, you will be taken off study. You may continue to take part in this study unless you no longer qualify for the study or you no longer would like to take part in this study.
This is an investigational study. Transvaginal ultrasound scans on this study are performed using FDA-approved and commercially available methods.
Up to 8,000 women will take part in this multicenter study. Up to 2,000 will be enrolled at MD Anderson.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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CA 125 Analysis
Experimental: CA 125, HE4, HE4 antigen autoantibody complexes, and Osteopontin Analysis Participants will have blood (3-4 tablespoons) drawn for CA125 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.
Questionnaire
Questionnaires completed at baseline and during each follow up visit.
Interventions
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Questionnaire
Questionnaires completed at baseline and during each follow up visit.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
50 Years
74 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Golfers Against Cancer
UNKNOWN
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Denise Nebgen, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas MD Anderson Cancer Center
Locations
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Sylvester Comprehensive Cancer Center, Univ of Miami Miller School of Medicine
Miami, Florida, United States
John Stoddard Cancer Center
Des Moines, Iowa, United States
Carol G. Simon Cancer Center / Atlantic Health
Morristown, New Jersey, United States
University of Rochester Medical Center
Rochester, New York, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Women's and Infant's Hospital
Providence, Rhode Island, United States
The University of Texas at Austin
Austin, Texas, United States
University of Texas (UT) Southwestern Medical Center
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Women's Hospital of Texas, Obstetrics and Gynecology Associates (OGA)
Houston, Texas, United States
UT Health Science Center San Antonio
San Antonio, Texas, United States
Countries
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Central Contacts
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Study Coordinator MD Anderson
Role: CONTACT
Facility Contacts
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Richard Moore, MD
Role: primary
Laura Holman, MD
Role: primary
Marian Williams-Brown, MD
Role: primary
Georgia McCann, MD
Role: primary
References
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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.
Related Links
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M D Anderson Cancer Center
Other Identifiers
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RP160145
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NCI-2018-02168
Identifier Type: REGISTRY
Identifier Source: secondary_id
ID01-022
Identifier Type: -
Identifier Source: org_study_id
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