Clinical trial · Interventional
Nipple Aspirate Fluid in Detecting Breast Cancer
Phi29 Motor Nanopore for Single Molecule Sensing: Breast Nipple Aspirate Fluid
NCT03715959CI-TRIAL-00086454completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (28)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage IA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage II Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage III Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIC Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IV Breast Cancer AJCC v8 | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspiration of Breast | Procedure | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (nipple aspiration fluid)
- description
- Participants and healthy volunteers undergo collection of nipple aspirate fluid from both breasts.
- interventionNames
- Procedure: Aspiration of Breast
- Procedure: Biospecimen Collection
Primary outcomes (1)
- measure
- Biomarkers expression levels
- timeFrame
- Up to 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.