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

50 Years
74 Years
Open (Enrolling)
Ovarian Cancer

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Trial Information

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

Currently, there are no effective tests to detect ovarian cancer at its earliest stage.
CA-125 is an FDA approved marker for detecting recurrence of disease in women who have
already had ovarian cancer.

Women who are at least 50 years old, who are post-menopausal, are eligible for this study.
Patients will have their blood drawn each year for the duration of the study. The amount of
blood drawn will be about 2 to 3 tablespoons.

Women will need to provide the name of a gynecologist or qualified healthcare professional
willing to provide follow up care if it is indicated.

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

An ultrasound test uses sound waves to evaluate the position, size, and shape of the
ovaries. During an ultrasound, a small probe will be used to generate and measure sound
waves. It will be placed in the vagina. Based on the results of the transvaginal
ultrasound, patients and their physician will discuss options for management. At this
point, standard clinical management ensues.

Patient's will be asked to complete a questionnaire. Patient's will be contacted to obtain
follow up information, and to ensure that they return for their blood draws. When patients
return for screening, their health status will be updated prior to, or at each visit. Any
changes to the participant's medical or cancer history will be obtained at that time.
Attempts will be made to contact patients by telephone or letter that are not seen during
visits. Updates to each participant's cancer history may also be obtained via M. D.
Anderson's medical informatics section, if an M. D. Anderson patient, or state tumor

Patients' names will not be used at any time. Each sample will have an identifying number.
Only the study coordinator will have the match between the identifying number and the
patient's name.

This is an investigational study. A total of 30,000 women will take part in this study.
Women will be enrolled in the study during Year 1 thru Year 15 of the study. An additional
year, Year 16, will be for follow-up. For example, a woman enrolled in the beginning of
Year 1 will participate for sixteen years. A woman enrolled in the beginning of Year 2
will participate for fifteen years and a woman enrolled in the beginning of Year 3 will
participate for fourteen years and so on. Women will be enrolled at John Stoddard Cancer
Center, Des Moines, Iowa, Women's and Infant's Hospital in Providence, Rhode Island; The
University of Texas M.D. Anderson Cancer Center, Houston, Texas, UT Southwestern, Dallas,
Texas and Carol G. Simon Cancer Center, Morristown, New Jersey. In order to increase
community participation in Houston, Texas a free-standing physician practice, Obstetrics and
Gynecology Associates (OGA), has been been added.

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 UTMD Anderson Cancer Center (UTMDACC)for CA 125 blood tests
annually or earlier if indicated

6. 6) Willingness to return to UTMDACC 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

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Rate of increase in CA 125 levels over time

Outcome Time Frame:

Once a year (Initial CA 125 test followed by another in 3 months or 12 months depending on initial assessment)

Safety Issue:


Principal Investigator

Karen H. Lu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2001

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Ovarian Cancer
  • CA 125 Algorithm
  • Cancer Detection
  • Questionnaire
  • Survey
  • Ovarian Neoplasms



John Stoddard Cancer Center Des Moines, Iowa  50309
UT MD Anderson Cancer Center Houston, Texas  77030
Women's and Infant's Hospital Providence, Rhode Island  02905
Baylor -Sammons Breast Center Dallas, Texas  75246
University of Texas Physicians-Family Practice Associates Houston, Texas  77030