Recruiting

CA 125 Algorithm

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT00539162

Conditions

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Questionnaire

Study Details

Brief summary:

The goal of this clinical research study is to find out if combining a standard blood test (CA-125) that checks for ovarian cancer with other blood tests that check for related tumor markers may be helpful in the early detection of ovarian cancer in women who are at low risk. Tumor markers are substances in the blood that may be related to ovarian cancer.

Conditions

Ovarian Cancer

Study ID

NCT00539162

Start date

Jul 2, 2001

Status verified date

Apr, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50 - 70+

Healthy Volunteers: Accepted

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

Enrollment

8000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: CA 125 Analysis

Experimental: CA-125 Analysis

Experimental: CA-125, HE4, and Osteopontin bio-marker analysis. Participants will have blood (3-4 tablespoons) drawn for CA-125 and other tumor markers.

Depending on CA-125 level and other tumor markers:

Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers in 1 year.

Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers in 3 months, OR

Blood (3-4 tablespoons) drawn for CA-125 testing and other tumor markers, and a transvaginal ultrasound in 6 weeks +/- 2 weeks.

Interventions

Questionnaire

Questionnaires completed at baseline and during each follow up visit.

Primary outcome measure

  • Rate of increase in CA 125 levels and other tumor markers 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. ]

Central Contacts and Locations

Central contacts

Study Coordinator MD Anderson

713-563-6728

Locations

Sylvester Comprehensive Cancer Center, Univ of Miami Miller School of Medicine

Recruiting

Miami, Florida, United States, 33136

Principal Investigator:

Brian Slomovitz, MD

John Stoddard Cancer Center

Recruiting

Des Moines, Iowa, United States, 50309

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55454

Carol G. Simon Cancer Center / Atlantic Health

Recruiting

Morristown, New Jersey, United States, 07962

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Women's and Infant's Hospital

Recruiting

Providence, Rhode Island, United States, 02905

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Denise H. Nebgen, MD, PHD, MD, PHD

Women's Hospital of Texas, Obstetrics and Gynecology Associates (OGA)

Recruiting

Houston, Texas, United States, 77054

UT Health Science Center San Antonio

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 6, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-06.