The Breast Cancer and Microbiota study is examining the impact of bacteria on the development of breast cancer.

What is the purpose of this study?

The purpose of this study is to try to determine the cause of breast cancer and examine whether a link may exist between diet, hormones and intestinal bacteria. One of the most important factors thought to play a role in breast cancer development is female hormones called estrogens, which can be made by the human body or taken into the body from the outside environment. Both types of estrogens may have an impact on the development of breast cancer in some women. Estrogens that are not made naturally in the body may increase the risk of breast cancer in some women. Because the intestinal bacteria affect the circulation and absorption of female hormones such as estrogen, bacteria and the systems that metabolize female hormones in the bacteria may hold clues to why certain people develop breast cancer and others do not.

Who is eligible to participate in the study?

The study is recruiting two groups: patients recently diagnosed with breast cancer and healthy controls. The study will compare the intestinal bacteria in women recently diagnosed with breast cancer and healthy controls.

You may be eligible if you meet the following criteria:

• You are a woman between 40 and 70 years old
  
• You have recently been diagnosed with breast cancer
  
• You have not yet received chemotherapy or radiation

• You are a woman between 50 and 70 years of age
  
• You have not had a menstrual period for 12 months
  
• You have had a normal mammogram within the past nine months

How long would I be in the study?

The study requires you to come to Rush University Medical Center for one visit. At this visit, we will obtain a brief medical history and a focused physical exam. Eligible individuals must be willing to provide a blood sample and either a) undergo an unprepped, limited flexible sigmoidoscopy or b) provide a stool sample.

Despite there only being one visit, you can expect to be in the study for one year because we will be looking at your medical records and charts. During this time, we may need to call you to obtain any missing information.

What are the benefits of taking part in the study?

There may be no direct benefit to you for participating in this study. If you choose to participate in this study, you will be increasing scientific knowledge about the effect of bacteria on breast cancer. Such knowledge may lead to completely new treatments or tools for early detection of breast cancer for a high-risk individual.

What is the compensation for this study?

You will be compensated $250 for your time and effort if you choose to undergo the limited, flexible sigmoidoscopy.

If you elect not to undergo the procedure, you will be compensated $50 for providing stool and blood samples, and for filling out the questionnaires. Compensation will be provided to you after completion of all the study requirements. You will also be given a parking sticker or $8 (the same as the cost of a parking sticker) for bus fare or other transportation costs.

Where can I find further information about the study?Ece Mutlu, MD, the study's principal investigator, was featured on ABC-7 and WGN for her research in determining the cause of breast cancer. Click on the links below to the article and video:

ABC-7 video/article
WGN video/article

You may also contact our study coordinator, Andrew Walker, at (312) 942-9203. You may also find information in the clinical trials database on the Rush Web site.