Nipple Aspirate Fluid in Detecting Breast Cancer

Not Applicable

Completed

• Conditions: 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
• Interventions: Procedure: Aspiration of Breast; Procedure: Biospecimen Collection

• Registration Number: NCT03715959
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-10-19
• Study First Posted: 2018-10-23
• Study Start: 2020-12-10
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-22
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (nipple aspiration fluid)	Aspiration of Breast	Participants and healthy volunteers undergo collection of nipple aspirate fluid from both breasts.
Diagnostic (nipple aspiration fluid)	Biospecimen Collection	Participants and healthy volunteers undergo collection of nipple aspirate fluid from both breasts.

Primary Outcome Measures

Name	Time	Method
Biomarkers expression levels	Up to 1 year	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.

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States