Nipple Aspirate Fluid in Detecting Breast Cancer

The Ohio State University

Status: Completed

Conditions: Anatomic Stage III Breast Cancer AJCC V8; Healthy Subject; Anatomic Stage IV Breast Cancer AJCC V8; Anatomic Stage IIIA Breast Cancer AJCC V8; Prognostic Stage IA Breast Cancer AJCC V8; Anatomic Stage IB Breast Cancer AJCC V8; Prognostic Stage I Breast Cancer AJCC V8; Prognostic Stage IV Breast Cancer AJCC V8; Triple-Negative Breast Carcinoma; Luminal B Breast Carcinoma; Anatomic Stage IA Breast Cancer AJCC V8; Anatomic Stage IIIB Breast Cancer AJCC V8; Luminal a Breast Carcinoma; Prognostic Stage IIIB Breast Cancer AJCC V8; Progesterone Receptor Negative; Anatomic Stage IIIC Breast Cancer AJCC V8; HER2/Neu Negative; HER2 Positive Breast Carcinoma; Prognostic Stage IIIC 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; Anatomic Stage IIA Breast Cancer AJCC V8; Prognostic Stage IB Breast Cancer AJCC V8; Anatomic Stage IIB Breast Cancer AJCC V8; Estrogen Receptor Negative; Anatomic Stage II Breast Cancer AJCC V8

Treatments: Procedure: Aspiration of Breast; Procedure: Biospecimen Collection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03715959

NCI-2018-01437 (Registry Identifier)

OSU-16288

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2 patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Diagnostic (nipple aspiration fluid)

Experimental group

Description:

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

Treatment:

Procedure: Biospecimen Collection

Procedure: Aspiration of Breast