Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The goal of this clinical research study is to evaluate a method involving a blood test,
called CA-125, that may be helpful in the early detection of ovarian cancer in women who are
at low risk.
Phase
N/A
Funding Agency/Sponsor
Externally Peer-Reviewed
Disease
Gynecologic Cancer
Enrollment Eligibility
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.