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

  • STATUS
    Recruiting
  • days left to enroll
    87
  • participants needed
    8000
  • sponsor
    M.D. Anderson Cancer Center
Updated on 23 January 2021
cancer chemotherapy
cancer antigen 125
cancer of the ovary

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.

Description

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.

Details
Condition Ovarian disorder, Ovarian Cancer, Ovarian Function, Recurrent Ovarian Cancer, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, ovarian tumors
Treatment Questionnaire, transvaginal ultrasound, CA 125 Analysis
Clinical Study IdentifierNCT00539162
SponsorM.D. Anderson Cancer Center
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 50 yrs and 74 yrs?
Are you female?
Do you have Ovarian Cancer?
Do you have any of these conditions: Ovarian Function or Recurrent Ovarian Cancer or cancer ovarian or ovarian tumors or Ovarian disorder or cancer of the ovary or cancer, ovarian or ovar...?
Female, >/= 50 years old or less than 75 years old
Postmenopausal (>/= 12 months amenorrhea)
Have at least one ovary
Cancer-free and have not received any chemotherapy or radiation therapy for >/=12 months prior to enrolling on this study
Willingness to return for CA 125 blood tests annually or earlier if indicated
Willingness to return to undergo transvaginal ultrasound if indicated
Women need to provide the name of a gynecologist or qualified healthcare professional willing to provide appropriate follow-up care if indicated

Exclusion Criteria

Female: Less than 50 years old or older than 75 years at the time of enrollment
Psychiatric or psychological or other conditions which prevent a fully informed consent
Prior removal of both ovaries
Active non-ovarian malignancy
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
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.)
Hereditary Nonpolyposis Colorectal Cancer (HNPCC)/Lynch Syndrome: known genetic mutation, presumed HNPCC carrier, Amsterdam criteria
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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