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Nipple Aspirate Fluid in Detecting Breast Cancer

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03715959
Collaborator
National Cancer Institute (NCI) (NIH)
100
Enrollment
1
Location
1
Arm
41.2
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Aspiration of Breast
  • Procedure: Biospecimen Collection
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. To obtain nipple aspirate fluid (NAF) samples from non-lactating women subjects at least 40-years-old.

  2. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Phi29 Motor Nanopore for Single Molecule Sensing: Breast Nipple Aspirate Fluid
Actual Study Start Date :
Jul 25, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
William Carson, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT03715959
Other Study ID Numbers:
  • OSU-16288
  • NCI-2018-01437
  • P30CA016058
First Posted:
Oct 23, 2018
Last Update Posted:
Nov 1, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Breast Neoplasms

Study Results

No Results Posted as of Nov 1, 2021