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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00539162
First received: October 3, 2007
Last updated: April 13, 2017
Last verified: April 2017
October 3, 2007
April 13, 2017
July 2, 2001
July 1, 2018   (Final data collection date for primary outcome measure)
Rate of increase in CA 125 levels over time [ Time Frame: Once a year (Initial CA 125 test followed by another in 3 months or 12 months depending on initial assessment) ]
Not Provided
Complete list of historical versions of study NCT00539162 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women
Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women
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.

Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Yearly blood draw of 2 to 3 tablespoons, with CA-125 analysis performed each time. Urine specimen obtained at each UT MDACC visit.
Non-Probability Sample
Study participants considered to be at low risk for ovarian cancer.
Ovarian Cancer
Behavioral: Questionnaire
Completed during follow up visits.
Other Name: Survey
CA 125 Analysis
Participants considered to be at low risk for ovarian cancer complete questionnaires.
Intervention: Behavioral: Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
8000
July 2018
July 1, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
50 Years to 74 Years   (Adult, Senior)
No
Contact: Gwen H. Corrigan 713-563-1790
Contact: Study Coordinator MD Anderson 713-563-6728
United States
 
 
NCT00539162
ID01-022
RP160145 ( Other Grant/Funding Number: CPRIT )
U01CA200462 ( U.S. NIH Grant/Contract )
P50CA083639 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Karen H. Lu, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP