Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

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
  • Triple-Negative Breast Carcinoma
  • Prognostic Stage IIB Breast Cancer AJCC v8
  • HER2/Neu Negative
  • Prognostic Stage IIIC Breast Cancer AJCC v8
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Prognostic Stage II Breast Cancer AJCC v8
  • Anatomic Stage IIB Breast Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Progesterone Receptor Negative
  • Prognostic Stage IB Breast Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • HER2 Positive Breast Carcinoma
  • Prognostic Stage I Breast Cancer AJCC v8
  • Healthy Subject
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Prognostic Stage IA Breast Cancer AJCC v8
  • Prognostic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IV Breast Cancer AJCC v8
  • Luminal B Breast Carcinoma
  • Estrogen Receptor Negative
  • Luminal A Breast Carcinoma
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 40 years and 125 years
Gender
Only males

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 b...

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.

Tracking Information

NCT #
NCT03715959
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: William Carson, MD Ohio State University Comprehensive Cancer Center