An interventional study of Aspiration of Breast and Biospecimen Collection in Anatomic Stage IA Breast Cancer AJCC V8, Anatomic Stage IB Breast Cancer AJCC V8 and Anatomic Stage II Breast Cancer AJCC V8, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to female participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-25.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Diagnostic
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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 2 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
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Exclusion Criteria:
Participants and healthy volunteers undergo collection of nipple aspirate fluid from both breasts.
Procedure: Aspiration of Breast · Procedure: Biospecimen Collection
Undergo NAF
Undergo NAF
Biomarkers expression levels
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.
Time frame: Up to 1 year
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Ohio State University Comprehensive Cancer Center