Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

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

Depending on CA-125 level:

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

Blood (about 2-3 tablespoons) drawn for CA-125 testing and other tumor markers in 3 months, OR Blood (about 2-3 tablespoons) drawn for CA-125 testing and other tumor markers, and a transvaginal ultrasound in 6 weeks +/- 2 weeks.

Questionnaires completed at baseline and during each follow up visit.

Questionnaires completed at baseline and during each follow up visit.

Questionnaire

Gwen H. Corrigan

Study Coordinator MD Anderson

Brian Slomovitz, MD

Richard Moore, MD

Laura Holman, MD

Marian Williams-Brown, MD

Karen H. Lu, MD

Georgia McCann, MD

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.

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.

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

National Cancer Institute (NCI)

Golfers Against Cancer

M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for ca 125 algorithm