Use of CA125 and Complementary Biomarkers for the Early Detection of Ovarian Cancer in Low Risk Women

Part of paid clinical trials in Miami, Florida.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00539162
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
50 Years - 74 Years
Healthy Volunteers
Accepted

Interventions

  • Questionnaire — BEHAVIORAL
    Questionnaires completed at baseline and during each follow up visit.

Study Details

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.

Key Dates

Start date
Jul 2, 2001
Status verified
Apr 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
8,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

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.

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

Locations (12)

FacilityCityStateZIPSite coordinators
Sylvester Comprehensive Cancer Center, Univ of Miami Miller School of MedicineMiamiFlorida33136
Brian Slomovitz, MD (PRINCIPAL_INVESTIGATOR)
John Stoddard Cancer CenterDes MoinesIowa50309-
University of MinnesotaMinneapolisMinnesota55454
Samantha Hoffman, MD
Carol G. Simon Cancer Center / Atlantic HealthMorristownNew Jersey07962-
University of Rochester Medical CenterRochesterNew York14642
Richard Moore, MD
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Laura Holman, MD
Women's and Infant's HospitalProvidenceRhode Island02905-
The University of Texas at AustinAustinTexas78712-
University of Texas (UT) Southwestern Medical CenterDallasTexas75390-
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Denise H. Nebgen, MD, PHD, MD, PHD (PRINCIPAL_INVESTIGATOR)
Women's Hospital of Texas, Obstetrics and Gynecology Associates (OGA)HoustonTexas77054-
UT Health Science Center San AntonioSan AntonioTexas78229
Georgia McCann, MD

Find similar trials in Miami, FL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Sylvester Comprehensive Cancer Center, Univ of Miami Miller School of Medicine· Miami, FLJohn Stoddard Cancer Center· Des Moines, IAUniversity of Minnesota· Minneapolis, MNCarol G. Simon Cancer Center / Atlantic Health· Morristown, NJUniversity of Rochester Medical Center· Rochester, NYUniversity of Oklahoma Health Sciences Center· Oklahoma City, OK

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