Clinical trial NCT03715959: Nipple Aspirate Fluid in Detecting Breast Cancer
Official title: Phi29 Motor Nanopore for Single Molecule Sensing: Breast Nipple Aspirate Fluid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 2
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Biomarkers expression levels
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: William Carson, MD
role: PRINCIPAL_INVESTIGATOR
References: