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Project Title Inflammation Changes Over Time In Obese, Overweight, and Normal Weight Women

Researcher Edward Sauter, MD, PhD, M.H.A., University of Texas Health Sciences Center in Tyler, Texas

Study Summary The research team is studying nipple aspirate fluid and blood to determine if inflammation biomarkers are: 1. higher in breast fluid than in the circulating blood; 2. higher in obese and overweight women compared with normal weight women; and 3. more variable through the menstrual cycle of premenopausal women compared to postmenopausal women.

Who Can Participate? You can join the Inflammation Changes Over Time in Obese, Overweight, and Normal Weight Women study if you match ALL of these MAIN categories:

• You are a woman 18 years of age or older
• You have at least one intact breast that has not received radiation therapy
• You live near or are willing to travel (at your own expense) to the University of Texas Health Sciences Center in Tyler, Texas.

After you RSVP, the research team will ask you additional questions to be sure that this study is the right fit for you.

What Does Participation Involve? If you sign up for the Inflammation Changes Over Time in Obese, Overweight, and Normal Weight Women study, the research team will contact you by phone to confirm that you are eligible for the study. If you are eligible and decide to join, you will be asked to:

• Complete an informed consent form

• Complete a health history questionnaire

• Go to the University of Texas Health Sciences Center in Tyler, Texas, for approximately 10 study visits. The visits will occur approximately every three to four days over a 30 day-period. At these visits you will be asked to:
o Have your height and weight measured (first and last visits only) to calculate your BMI

o Have approximately 3 tablespoons of blood collected from a vein in your arm

o Have nipple aspirate fluid (NAF) collected from your breast ducts. Nipple aspiration involves warming the breast with moist towels, self-breast massage, and using a modified breast pump that generates mild suction on the nipple to collect fluid. No needles are involved.

There is no cost to you to participate in the study. The information you provide is confidential and will be kept private.

The researchers need to enroll up to 42 women in this study.

Where? University of Texas Health Sciences Center in Tyler, Texas