Purpose

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.

Category

IRB Number
20170396HU
NCT Number
NCT00539162
Sponsor
M.D. Anderson Cancer Center -



Study Contact

Marisa Fernandez
210-450-8016
fernandezm10@uthscsa.edu

Principal Investigator
Georgia McCann

Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu

Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu

Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu

Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu

Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu

Sally Kabro
210-567-3742
kabro@uthscsa.edu



Eligibility

Eligible Ages
Between 50 Years and 74 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Screening
Masking
None (Open Label)
Condition
  • Ovarian Cancer

    • Arm Groups

    ArmDescriptionIntervention
    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.
  • Behavioral: Questionnaire

    Questionnaires completed at baseline and during each follow up visit.

    Other names:

    • Survey

    •