CA-125 Algorithm in Early Screening for Ovarian Cancer in Low Risk Postmenopausal Participants
This trial studies how well CA-125 algorithm works in early screening for ovarian cancer in low risk postmenopausal participants. CA-125 may show the presence of ovarian cancer and be helpful in the early detection of ovarian cancer in women who are at low risk.
Inclusion Criteria
- Female, >= 50 years old and 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
Exclusion Criteria
- 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 selective estrogen receptor modulators (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 known familial predisposition as defined by the following: * Known mutation in BRCA1 or BRCA2. * Two first or second degree relatives of the same lineage who have: two ovarian cancers; one ovarian cancer & one pre-menopausal breast cancer; two premenopausal 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.) * Ashkenazi Jewish descent with one first degree or two second degree relatives with pre-menopausal breast or ovarian cancer or participant has had pre-menopausal breast cancer. * First or second 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
- Female: Less than 50 years old or older than 75 years at the time of enrollment
Additional locations may be listed on ClinicalTrials.gov for NCT00539162.
Locations matching your search criteria
United States
Florida
Miami
Iowa
Des Moines
New Jersey
Morristown
New York
Rochester
Oklahoma
Oklahoma City
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Texas
Austin
Houston
San Antonio
PRIMARY OBJECTIVES:
I. To evaluate the longitudinal CA-125 algorithm for the early detection of ovarian cancer in a low risk cohort of women.
II. To assess feasibility of population screening for ovarian cancer using the CA 125 algorithm in a low risk population.
III. To establish a serum and plasma bank that will allow more rapid assessment of specificity for novel markers and/or combinations of multiple markers for the early detection of ovarian cancer.
IV. To examine clinical information such as treatments, progression, recurrence, and overall survival in women who develop ovarian cancer.
V. To examine clinical information such as age, stage, grade, histotype, and date of diagnosis for women who develop non-ovarian cancer.
OUTLINE:
Participants undergo blood specimen collection at baseline and then either at 6 weeks, 3 months, or 1 year depending on baseline CA-125 level.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorDenise Renee Nebgen
- Primary IDID01-022
- Secondary IDsNCI-2018-02168
- ClinicalTrials.gov IDNCT00539162