Breast Cancer Clinical Trial

Pilot Study of Oxytocin and microRNA Identification in NAF, Serum, and Tissue in Women With Breast Cancer

Summary

The purpose of this study is to examine the genetic material called microRNA of three types of specimens from women with breast cancer. The study also seeks to examine the effectiveness of using a new agent called oxytocin to increase the amount of nipple fluid that can be collected during surgery.

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Full Description

Vast majority of breast cancers arise from ductal epithelium. Ductal cells can be collected through the nipple orifice very early in breast cancer development. The nipple aspirate fluid (NAF) can be used to identify biomarkers that predict risk of breast cancer. To date, the biomarkers identified in nipple aspirate fluid (NAF) have limited utility due to the large volume of NAF required for data analysis. Recent studies show intranasal oxytocin's utility in enhancing the yield of nipple aspirate fluid (NAF) among healthy, non-lactating female patients as well as those at high risk for breast cancer. This capability is crucial for the analysis of various markers associated with breast disease and cancer such as microRNAs. The primary aim of the study is to determine whether the microRNA profile characterization is feasible with the collection of tissue, serum and NAF in patients with in situ and invasive breast cancer. Intranasal oxytocin will be used to enhance fluid yielding of the NAF.

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Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Ductal carcinoma in situ (DCIS) or invasive breast cancer
Candidate for breast conserving surgery or mastectomy

Exclusion Criteria:

Pregnant women
Prior Breast Cancer diagnosis
Adverse reaction to Oxytocyn in the past

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT02127073

Recruitment Status:

Suspended

Sponsor:

Sheldon Feldman

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There is 1 Location for this study

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Columbia University Medical Center
New York New York, 10032, United States

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Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

40

Study ID:

NCT02127073

Recruitment Status:

Suspended

Sponsor:


Sheldon Feldman

How clear is this clinincal trial information?

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