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Nipple Aspirate Fluid in Detecting Breast Cancer

Primary Purpose

Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aspiration of Breast
Biospecimen Collection
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anatomic Stage IA Breast Cancer AJCC v8

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • Ohio State University Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (nipple aspiration fluid)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 19, 2018
Last Updated
February 26, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03715959
Brief Title
Nipple Aspirate Fluid in Detecting Breast Cancer
Official Title
Phi29 Motor Nanopore for Single Molecule Sensing: Breast Nipple Aspirate Fluid
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Estrogen Receptor Negative, Healthy Subject, HER2 Positive Breast Carcinoma, HER2/Neu Negative, Luminal A Breast Carcinoma, Luminal B Breast Carcinoma, Progesterone Receptor Negative, 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, Prognostic Stage IV Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (nipple aspiration fluid)
Arm Type
Experimental
Arm Description
Participants and healthy volunteers undergo collection of nipple aspirate fluid from both breasts.
Intervention Type
Procedure
Intervention Name(s)
Aspiration of Breast
Intervention Description
Undergo NAF
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Intervention Description
Undergo NAF
Primary Outcome Measure Information:
Title
Biomarkers expression levels
Description
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.
Time Frame
Up to 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ohio State University Comprehensive Cancer Center
Phone
800-293-5066
Email
OSUCCCClinicaltrials@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Carson, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Carson, MD
Phone
614-293-6306
Email
William.Carson@osumc.edu
First Name & Middle Initial & Last Name & Degree
William Carson, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

Nipple Aspirate Fluid in Detecting Breast Cancer

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