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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Identifying the miR Fingerprint in NAF, Serum, and Tissue in Patients With Ductal Carcinoma in Situ (DCIS) or Invasive Breast Cancer

Brief 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.

Detailed Summary: 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.
Sponsor: Sheldon Feldman

Current Primary Outcome: Percentage of patients with detection of microRNA in NAF, serum, or tissue [ Time Frame: 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Percentage of patients with collection of ≥ 5 μL of nipple aspirate fluid [ Time Frame: 3 years ]

Original Secondary Outcome: Same as current

Information By: Montefiore Medical Center

Dates:
Date Received: April 28, 2014
Date Started: March 2014
Date Completion: March 2019
Last Updated: February 12, 2017
Last Verified: February 2017