Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women

Currently, there is no effective screening to detect ovarian cancer at its earliest stage in
low risk women. CA-125 is an FDA approved blood test that may show the presence of ovarian
cancer.

If you are eligible to take part in this research study:

- You will have blood (about 2-3 tablespoons) drawn for CA-125 testing and other tumor
markers. Tumor markers may be related to the presence of certain cancers.

- 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 2-3 tablespoons) drawn for CA-125 testing and other tumor
markers in 1 year.

- You will have blood (about 2-3 tablespoons) drawn for CA-125 testing and other tumor
markers in 3 months, OR

- You will have blood (about 2-3 tablespoons) drawn for CA-125 testing 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 2-3 tablespoons) drawn for CA-125 testing and other tumor
markers in 3 months.

When you return for your next visit (at 1 year, 3 months, or 6 weeks +/- 2 weeks), and each
visit after that:

- You will have blood (about 2-3 tablespoons) drawn for CA-125 testing and other tumor
markers.

- 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 CA-125 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.

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.

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.