NCT03715959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
2.1 years until next milestone

Study Start

First participant enrolled

December 10, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

3.1 years

First QC Date

October 19, 2018

Last Update Submit

February 22, 2025

Conditions

Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Estrogen Receptor NegativeHealthy SubjectHER2 Positive Breast CarcinomaHER2/Neu NegativeLuminal A Breast CarcinomaLuminal B Breast CarcinomaProgesterone Receptor NegativePrognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8Prognostic Stage IV Breast Cancer AJCC v8Triple-Negative Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Diagnostic (nipple aspiration fluid)

EXPERIMENTAL

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

Procedure: Aspiration of BreastProcedure: Biospecimen Collection

Interventions

Aspiration of BreastPROCEDURE

Undergo NAF

Diagnostic (nipple aspiration fluid)
Biospecimen CollectionPROCEDURE

Undergo NAF

Diagnostic (nipple aspiration fluid)

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • William Carson, MD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 19, 2018

First Posted

October 23, 2018

Study Start

December 10, 2020

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)