Trials / Completed
CompletedNCT03715959
Nipple Aspirate Fluid in Detecting Breast Cancer
Phi29 Motor Nanopore for Single Molecule Sensing: Breast Nipple Aspirate Fluid
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Ohio State University Comprehensive Cancer Center · Academic / Other
- Sex
- Female
- Age
- 40 Years
- Healthy volunteers
- Accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Aspiration of Breast | Undergo NAF |
| PROCEDURE | Biospecimen Collection | Undergo NAF |
Timeline
- Start date
- 2020-12-10
- Primary completion
- 2024-01-01
- Completion
- 2024-01-01
- First posted
- 2018-10-23
- Last updated
- 2025-02-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03715959. Inclusion in this directory is not an endorsement.