Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00539162|
Recruitment Status : Recruiting
First Posted : October 4, 2007
Last Update Posted : September 15, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Behavioral: Questionnaire||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women|
|Actual Study Start Date :||July 2, 2001|
|Estimated Primary Completion Date :||July 31, 2023|
|Estimated Study Completion Date :||July 31, 2023|
Experimental: CA 125 Analysis
Participants will have blood (about 2-3 tablespoons) drawn for CA-125 testing and other tumor markers.
Depending on CA-125 level:
Blood (about 2-3 tablespoons) drawn for CA-125 testing and other tumor markers in 1 year.
Blood (about 2-3 tablespoons) drawn for CA-125 testing and other tumor markers in 3 months, OR Blood (about 2-3 tablespoons) drawn for CA-125 testing and other tumor markers, and a transvaginal ultrasound in 6 weeks +/- 2 weeks.
Questionnaires completed at baseline and during each follow up visit.
Questionnaires completed at baseline and during each follow up visit.
Other Name: Survey
- Rate of increase in CA 125 levels over time [ Time Frame: 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. ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||50 Years to 74 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539162
|Contact: Gwen H. Corriganfirstname.lastname@example.org|
|Contact: Study Coordinator MD Anderson||713-563-6728|
|United States, Florida|
|Sylvester Comprehensive Cancer Center, Univ of Miami Miller School of Medicine||Recruiting|
|Miami, Florida, United States, 33136|
|Principal Investigator: Brian Slomovitz, MD|
|United States, Iowa|
|John Stoddard Cancer Center||Recruiting|
|Des Moines, Iowa, United States, 50309|
|United States, New Jersey|
|Carol G. Simon Cancer Center / Atlantic Health||Recruiting|
|Morristown, New Jersey, United States, 07962|
|United States, New York|
|University of Rochester Medical Center||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Richard Moore, MD|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Laura Holman, MD|
|United States, Rhode Island|
|Women's and Infant's Hospital||Recruiting|
|Providence, Rhode Island, United States, 02905|
|United States, Texas|
|The University of Texas at Austin||Recruiting|
|Austin, Texas, United States, 78712|
|Contact: Marian Williams-Brown, MD|
|University of Texas (UT) Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Karen H. Lu, MD|
|Women's Hospital of Texas, Obstetrics and Gynecology Associates (OGA)||Recruiting|
|Houston, Texas, United States, 77054|
|UT Health Science Center San Antonio||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Georgia McCann, MD|
|Principal Investigator:||Karen H. Lu, MD||M.D. Anderson Cancer Center|
|Responsible Party:||M.D. Anderson Cancer Center|
|Other Study ID Numbers:||
RP160145 ( Other Grant/Funding Number: CPRIT )
U01CA200462 ( U.S. NIH Grant/Contract )
P50CA083639 ( U.S. NIH Grant/Contract )
NCI-2018-02168 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
|First Posted:||October 4, 2007 Key Record Dates|
|Last Update Posted:||September 15, 2022|
|Last Verified:||September 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
CA 125 Algorithm
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type