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Project Title Breast Cancer Microbiota Study

Researcher Ece Mutlu, MD, Rush University Medical Center, Chicago, Illinois

Study Summary The purpose of this study is to find out what types of bacteria are found in the intestines and how these bacteria metabolize estrogen and other female hormones. The researchers are comparing the bacteria found in women who have never had breast cancer, women who have been diagnosed with breast cancer within the last 5 years, and women who have never had breast cancer but who have a first-degree relative WITH breast cancer.

Who Can Participate? You can join the Breast Cancer Microbiota Study if you match ALL of these MAIN categories:

• You are a woman between the ages of 30 – 80
• You have NOT had a serious illness requiring immediate hospitalization in the last month
• You have NOT been diagnosed with a gastrointestinal disease (hemorrhoids or hiatal hernia are OK)
• You do NOT have liver, kidney, or lung disease or heart failure
• You do NOT have human immunodeficiency virus (HIV)
• You have NOT received an organ transplant
• You have NOT taken immunosuppressive medications or antibiotics within 3 months of participating in the study
• You have NOT received chemotherapy or radiation treatment within 1 month of participating in the study
• You do NOT have a history of colonic disease such as colon cancer or inflammatory bowel disease
• You are NOT pregnant or breastfeeding
• You are able to go to Rush University Medical Center in Chicago, Illinois, OR participating Quest Diagnostics locations in the Chicago, Illinois metropolitan area (specific locations will be provided by the research team after you RSVP for the study):

The researchers are recruiting for two groups. In order to participate in this study:
• You have been diagnosed with breast cancer (any stage, including DCIS and metastatic disease) within the last 5 years

OR

You MUST match ALL of these catagories to be eligible:
• You do NOT have a personal history of breast cancer.
• You do NOT have a first degree female relative (mother, sister, or daughter) who was diagnosed with breast cancer.
• You had a mammogram with no abnormalities but benign findings with the last 5 years. (Mammogram Codes 3 or 4)

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

What Does Participation Involve? If you join the Breast Cancer Microbiota Study you will be contacted by the research team to answer questions about your health history. If you are eligible for the study and decide to participate, you will be asked to complete a packet of study questionnaires about your health, smoking and alcohol consumption, physical activity, and family health; a gastrointestinal (GI) symptom checklist; and a breast cancer risk factor questionnaire. You will receive and return all questionnaires in the mail (at no cost to you). You will also be asked to complete an online diet history questionnaire. (The research team will send you the log-in information.) Additionally, the researchers will request your permission to access your medical records.

You will be asked to have blood drawn from a vein in your arm (about 7 tablespoons). If you live in the Chicago area, you can go to Rush University Medical Center for the blood collection. If you live in Illinois outside of Chicago you will be asked to go to one of the participating Quest Diagnostics locations for the blood collection. The research team will provide you with a list of Quest Diagnostics locations to choose from. No matter where you go for blood collection, there will be no cost to you. If you go to Quest Diagnostics for blood collection, the research team will mail you everything you will need, including instructions for making an appointment and the blood collection tubes. Quest Diagnostics will ship your blood samples to the researchers.

You will also be asked to provide two stool samples that you will collect from home. Samples should be collected approximately 7 days apart. The researchers will mail you a stool collection kit, including instructions for collection, collection and storage containers, and all supplies to return it to the researchers. You can return the kit to Rush University Medical Center or in the mail (at no cost to you).

You will also be contacted 2 years after the study is completed for a follow-up phone call.

Where? Rush University Medical Center, Chicago, Illinois and participating Quest Diagnostics locations in the Chicago metropolitan area