Nipple Aspirate Fluid in Detecting Breast Cancer

PRIMARY OBJECTIVES:

I. To obtain nipple aspirate fluid (NAF) samples from non-lactating women subjects at least
40-years-old.

II. To analyze the samples using a novel protein nanopore-based detection platform to
evaluate the efficacy of the platform for breast cancer diagnosis through detection of
biomarkers.

OUTLINE:

Participants and healthy volunteers undergo collection of nipple aspirate fluid from both
breasts.

After completion of study, participants are followed up at 1 year.

Inclusion Criteria:

- BREAST CANCER: Must be > 1 year from pregnancy, lactation.

- BREAST CANCER: Must be currently diagnosed with known breast cancer in breast.

- BREAST CANCER: Must not be currently diagnosed with cancers other than breast cancer.

- BREAST CANCER: Must not have been gone through surgery, radiotherapy or chemotherapy
within 30 days of enrollment.

- HEALTHY SUBJECTS: No history of breast cancer and must not be currently diagnosed with
any other cancer.

- HEALTHY SUBJECTS: Must be > 1 year from pregnancy, lactation.

- HEALTHY SUBJECTS: Must be willing to have a clinical breast exam and/or mammogram
performed or reviewed by an Ohio State University (OSU) radiologist at the James
Cancer Hospital within the past 90 days prior to their NAF procedure. The clinical
breast exam result and/or mammograms must be read as not suspicious for breast cancer.

- HEALTHY SUBJECTS: Must be willing to keep the clinic informed of their breast health
status for 1 year.

Exclusion Criteria:

- Subjects who are currently pregnant, lactating, or within a year of
pregnancy/lactation. Pregnancy testing will not be required of any patients over 60
years of age, or any patient who has undergone bilateral oophorectomy.

- Subjects who currently are diagnosed with cancers other than breast cancer.

- Subjects who cannot give an informed consent.

- Male gender of any age.