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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • 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
  • Breast Neoplasms
  • Carcinoma
  • 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

NCT number NCT03715959
Study type Interventional
Source Ohio State University Comprehensive Cancer Center
Contact
Status Active, not recruiting
Phase N/A
Start date July 25, 2019
Completion date December 31, 2024

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