Early Detection of Ovarian Cancer

Study ID

Cancer Related

Healthy Volunteers

Study Sites

  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Parkland Health & Hospital System

Isabel Villalobos

Principal Investigator
Siobhan Kehoe, M.D.

Official Title

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

Brief Overview

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
post-menopausal women.


Currently, there are no effective tests to detect ovarian cancer at its earliest stage.
CA-125 is an FDA approved marker for detecting if the disease has come back in women who
have already had ovarian cancer. Tumor markers may be related to the status of the disease.

If you are eligible to take part in this research study, you will have blood (about 2-3
tablespoons) drawn every year while on study.

You will need to provide the name of a gynecologist or qualified healthcare professional
willing to provide follow-up care, if needed.

Each time blood is drawn, the CA-125 analysis will be performed. If the CA-125 analysis
shows that you are at a low risk of developing ovarian cancer, you will be asked to repeat
the blood test in one year. If the CA-125 analysis shows that you are at a slightly higher
risk, you will be asked to repeat the blood test in 3 months. If the CA-125 analysis shows
that you are at an even higher risk, you will be asked to have a transvaginal ultrasound.

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, you and
the study doctor will discuss options for further treatment or standard cancer management.

All study participants will be asked to complete a questionnaire. You will be contacted to
collect follow-up information, and to make sure that you return for the follow-up blood
draws. When you return for screening, your health status will be updated in your medical
record before or at each visit, and any changes to your medical or cancer history will be
noted. If you were not seen at a visit, the study staff will try to contact you by telephone
or letter. Your medical information may also be updated using MD Anderson's Medical
Informatics Section, or state tumor registries.

Your name or other identifying information will not be used at any time blood samples are
drawn. Each sample will have an identifying number. Only the study coordinator will have the
match between the identifying number and your identity.

Length of Participation:

Women will be enrolled on this study for up to 15 years, plus 1 year of follow-up. Your
participation on this study may last up to 16 years.

This is an investigational study. Transvaginal ultrasound scans on this study are performed
using FDA-approved and commercially available methods.

Up to 30,000 women will take part in this multicenter study. Up to 9500 will be enrolled at
MD Anderson.

Participant 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 to MD Anderson for CA 125 blood tests annually or earlier if

6. Willingness to return to MD Anderson 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

2. Psychiatric or psychological or other conditions which prevent a fully informed

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 SERM (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 : a. known mutation in BRCA1 of BRCA2.

7. Two 1st or 2nd degree relatives of same lineage who have: two ovarian cancers; one
ovarian cancer and one pre-menopausal breast cancer; two pre-menopausal breast
cancers; one pre-menopausal and one post menopausal breast cancer. These conditions
can also be met using the participant and one 1st or 2nd degree female relative.

8. 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

9. 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.

10. HNPCC/Lynch Syndrome: known genetic mutation, presumed HNPCC carrier, Amsterdam