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Nipple Aspirate Fluid in Detecting Breast Cancer

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ClinicalTrials.gov Identifier: NCT03715959
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : August 1, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
William Carson, Ohio State University Comprehensive Cancer Center

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
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 Procedure: Aspiration of Breast Procedure: Biospecimen Collection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 25, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715959


Contacts
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Contact: Ohio State University Comprehensive Cancer Center 800-293-5066 OSUCCCClinicaltrials@osumc.edu

Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: William Carson, MD    614-293-6306    William.Carson@osumc.edu   
Principal Investigator: William Carson, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: William Carson, MD Ohio State University Comprehensive Cancer Center
Additional Information:
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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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA016058 ( U.S. NIH Grant/Contract )
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases