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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-74
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female, >/= 50 years old or less than 75 years old.

Postmenopausal (>/= 12 months amenorrhea).

Have at least one ovary.

Cancer-free and have not received any chemotherapy or radiation therapy for >/=12 months prior to enrolling on this study.

Disqualifiers

Female: Less than 50 years old or older than 75 years at the time of enrollment.

Psychiatric or psychological or other conditions which prevent a fully informed consent.

Prior removal of both ovaries.

Active non-ovarian malignancy.

Trial design

Design model

Single group

Treatments tested in this trial

  • Questionnaire

    Behavioral

    Questionnaires completed at baseline and during each follow up visit.

Treatment groups

8,000 Participants
are divided into 1 treatment group
Group A: CA 125 AnalysisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of increase in CA 125 levels and other tumor markers over time

\[Time Frame: Based on CA-125 level and other tumor markers, 3 options will result: 1) re-draw blood (CA-125 and other tumor markers) in 1 year, 2) re-draw blood (CA-125 and other tumor markers) in 3 months, or 3) re-draw blood (CA-125 and other tumor markers) and TVUS in 6 weeks +/- 2 weeks.\]

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Golfers Against Cancer

Collaborator