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

• ClinicalTrials.gov Identifier: NCT00539162
• Recruitment Status: Recruiting
• First Posted: October 4, 2007
• Last Update Posted: September 15, 2022
• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); Golfers Against Cancer
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Tracking Information

• First Submitted Date: October 3, 2007
• First Posted Date: October 4, 2007
• Last Update Posted Date: September 15, 2022
• Actual Study Start Date: July 2, 2001
• Estimated Primary Completion Date: July 31, 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 1, 2019): Rate of increase in CA 125 levels over time [ Time Frame: Based on CA-125 level, 3 options will result: 1) re-draw blood (CA-125) in 1 year, 2) re-draw blood (CA-125) in 3 months), or 3) re-draw blood (CA-125) AND TVUS in 6 weeks +/- 2 weeks. ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women
• Official Title: Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women
• Brief 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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Screening
• Condition: Ovarian Cancer

Intervention

Behavioral: Questionnaire

Questionnaires completed at baseline and during each follow up visit.

Other Name: Survey

Study Arms

Experimental: CA 125 Analysis

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.

Intervention: Behavioral: Questionnaire

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 19, 2017): 8000
• Original Estimated Enrollment (submitted: October 3, 2007): 14602
• Estimated Study Completion Date: July 31, 2023
• Estimated Primary Completion Date: July 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 50 Years to 74 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Gwen H. Corrigan; 713-563-1790; gcorriga@mdanderson.org

Contact: Study Coordinator MD Anderson; 713-563-6728

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00539162
• Other Study ID Numbers: ID01-022; RP160145 ( Other Grant/Funding Number: CPRIT ); U01CA200462 ( U.S. NIH Grant/Contract ); P50CA083639 ( U.S. NIH Grant/Contract ); NCI-2018-02168 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: M.D. Anderson Cancer Center
• Original Responsible Party: Not Provided
• Current Study Sponsor: M.D. Anderson Cancer Center
• Original Study Sponsor: Same as current

Collaborators

• National Cancer Institute (NCI)
• Golfers Against Cancer

Investigators

• Principal Investigator: Karen H. Lu, MD; M.D. Anderson Cancer Center

• PRS Account: M.D. Anderson Cancer Center
• Verification Date: September 2022