What this study is
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.
What's being tested
- Questionnaire
Intervention · BEHAVIORAL
Questionnaires completed at baseline and during each follow up visit.
Study details
- Sponsor
- M.D. Anderson Cancer Center
- Conditions
- Ovarian Cancer
- Enrolling
- 8,000 people
- Starts
- 2001-07-02
- Est. completion
- 2028-11-30
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 50 Years – 74 YearsSex FEMALEHealthy volunteers AcceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (12)
10 openSylvester Comprehensive Cancer Center, Univ of Miami Miller School of Medicine
Miami, Florida, United States
- Brian Slomovitz, MD · Principal investigator
RecruitingJohn Stoddard Cancer Center
Des Moines, Iowa, United States
RecruitingUniversity of Minnesota
Minneapolis, Minnesota, United States
- Samantha Hoffman, MD · Contact
RecruitingCarol G. Simon Cancer Center / Atlantic Health
Morristown, New Jersey, United States
RecruitingUniversity of Rochester Medical Center
Rochester, New York, United States
- Richard Moore, MD · Contact
RecruitingUniversity of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
- Laura Holman, MD · Contact
RecruitingWomen's and Infant's Hospital
Providence, Rhode Island, United States
RecruitingUniversity of Texas MD Anderson Cancer Center
Houston, Texas, United States
- Denise H. Nebgen, MD, PHD, MD, PHD · Principal investigator
RecruitingWomen's Hospital of Texas, Obstetrics and Gynecology Associates (OGA)
Houston, Texas, United States
RecruitingUT Health Science Center San Antonio
San Antonio, Texas, United States
- Georgia McCann, MD · Contact
RecruitingThe University of Texas at Austin
Austin, Texas, United States
Active, not recruitingUniversity of Texas (UT) Southwestern Medical Center
Dallas, Texas, United States
Active, not recruiting
Study team
Sponsor
M.D. Anderson Cancer Center
Study ID ID01-022
Principal investigator
Denise Nebgen, MD, PHD
M.D. Anderson Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.