Nipple Aspirate Fluid in Detecting Breast Cancer

February 22, 2025 updated by: William Carson, Ohio State University Comprehensive Cancer Center

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

Completed

Conditions

Intervention / Treatment

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 (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: William Carson, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2020

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

January 1, 2024

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 (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 22, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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