IRB #

STUDY00020449

Title

Diet, Microbiome and Interval Breast Cancer Study

Principal Investigator

Zhenzhen Zhang

Study Purpose

The goal of this study is to reduce the risk of breast cancer and identify novel risk factors and biomarkers for interval breast cancers, those diagnosed within 1 year after last normal mammogram.

Medical Condition(s)

Breast Cancer

Eligibility Criteria

BREAST CANCER (GROUP 1 &2) PARTICIPANT INCLUSION CRITERIA
To be eligible to participate in this study, an individual must meet all of the following criteria:

• Female postmenopausal participants
Definition of postmenopausal: if age 50-54, no menstrual period for at least 12 months; if age ≥ 55, no menstrual period for at least 6 months.)
• Age over 50-89 years old
• Biopsy confirmed diagnosis of breast cancer and before any treatment (surgery, chemotherapy or radiation therapy)
• For interval breast cancer patients, breast cancer was diagnosed after a non-suspicious routine mammographic screen within 1 year and before the next scheduled routine mammographic screen.
• For screen-detected breast cancer patients, breast cancer was diagnosed through routine mammogram screening.
• No record of inflammatory bowel disease or diverticulitis, gastric banding or by-pass surgery
• No record of history of other gastric or intestinal surgery (such as appendicitis) within the previous 6 months
• Verbally consent over the phone or signed informed consent through REDCap

HEALTHY CONTROL (GROUP 3) PARTICIPANT INCLUSION CRITERIA
• Female postmenopausal participants
Definition of 'postmenopausal' is the same for GROUP 1&2.
• Age over 50-89 years old
• No record of inflammatory bowel disease or diverticulitis, gastric banding or by-pass surgery
• No record of history of other gastric or intestinal surgery (such as appendicitis) within the previous 6 months
• Had a routine mammogram with a non-suspicious result within the past 2 years
• Verbally consent over the phone or signed informed consent through RedCap

BREAST CANCER AND CONTROL PARTICIPANT (ALL GROUPS) EXCLUSION CRITERIA
An individual who meets any of the following criteria will be excluded from participation in this study:

• History of prior cancer (other than non-melanoma skin cancer)
• Inflammatory bowel disease or diverticulitis, gastric banding or by-pass surgery
• History of other gastric or intestinal surgery (such as appendicitis) within the previous 6 months
• Have never done routine-mammogram screening within the past 2 years or the most routine mammogram result was suspicious that needs close follow-up
• Not able to legally consent, this population will be excluded by the fact that they will not be able to consent through the steps that would eliminate this population because they would not be able to complete the registration steps.
• Under 50 or above 89 years old

Age Range

50 - 89

Healthy Volunteers Needed

Yes

Duration of Participation

Up to 2 years

Minors Included

No

Contact

DMIBC@ohsu.edu
503-418-9665

Sponsor

Recruitment End

03/31/2021

Compensation Provided

Yes

Compensation

$20


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