Pilot Study of Oxytocin and microRNA Identification in NAF, Serum, and Tissue in Women With Breast Cancer
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.
Ductal Carcinoma in Situ
Drug: Intranasal Oxytocin
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Identifying the miR Fingerprint in NAF, Serum, and Tissue in Patients With Ductal Carcinoma in Situ (DCIS) or Invasive Breast Cancer|
- Percentage of patients with detection of microRNA in NAF, serum, or tissue [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Percentage of patients with collection of ≥ 5 μL of nipple aspirate fluid [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Subjects would receive 4 IU of intranasal oxytocin; one spray in each nostril, single-use.
Drug: Intranasal Oxytocin
Intranasal spray, one spray or 4 IU of oxytocin will be administered into each nostril of each patient about 15-30 minutes before NAF collection
Other Name: Syntocinon Spray
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02127073
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Sheldon Feldman, MD||Columbia University|