Nipple Aspirate Fluid in Detecting Breast Cancer

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

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.

Study Overview

• Status: Recruiting
• 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; 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; Anatomic Stage IV Breast Cancer AJCC v8; Prognostic Stage IV Breast Cancer AJCC v8; Estrogen Receptor Negative; HER2/Neu Negative; Progesterone Receptor Negative; Triple-Negative Breast Carcinoma; HER2 Positive Breast Carcinoma; Healthy Subject; Luminal A Breast Carcinoma; Luminal B Breast Carcinoma
• Intervention / Treatment: Procedure: Aspiration of Breast; Procedure: Biospecimen Collection

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 19, 2018
• First Submitted That Met QC Criteria: October 19, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 26, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Breast Diseases; Breast Neoplasms; Carcinoma
• Other Study ID Numbers: OSU-16288; NCI-2018-01437 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No