Nipple Aspirate Fluid in Detecting Breast Cancer

Study Overview
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Brief Summary
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This trial studies nipple aspirate fluid in detecting breast cancer. Nipple aspirate fluid may better detect breast cancer earlier than current methods used for screening such as mammograms and breast examinations.

Detailed Description
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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.

Official Title
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Phi29 Motor Nanopore for Single Molecule Sensing: Breast Nipple Aspirate Fluid

Conditions
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Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Negative, Healthy Subject, HER2 Positive Breast Carcinoma, HER2/Neu Negative, Luminal A Breast Carcinoma, Luminal B Breast Carcinoma, Progesterone Receptor Negative, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage IV Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma

Intervention / Treatment
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* Procedure: Aspiration of Breast
* Procedure: Biospecimen Collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (nipple aspiration fluid)<br>Participants and healthy volunteers undergo collection of nipple aspirate fluid from both breasts. | Procedure: Aspiration of Breast<br>* Undergo NAF<br>Procedure: Biospecimen Collection<br>* Undergo NAF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers expression levels | Nipple aspiration fluid samples will be compared between breast cancer participants and healthy participants. will perform the logistic regression model for each biomarker that shows any difference between the breast cancer patients and healthy individuals. Then we will include multiple biomarkers in one model while controlling for confounders. | Up to 1 year |