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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Columbia University
Sponsor:
Information provided by (Responsible Party):
Sheldon Feldman, Columbia University
ClinicalTrials.gov Identifier:
NCT02127073
First received: April 28, 2014
Last updated: May 10, 2014
Last verified: May 2014

April 28, 2014
May 10, 2014
March 2014
March 2015   (final data collection date for primary outcome measure)
Percentage of patients with detection of microRNA in NAF, serum, or tissue [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02127073 on ClinicalTrials.gov Archive Site
Percentage of patients with collection of ≥ 5 μL of nipple aspirate fluid [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pilot Study of Oxytocin and microRNA Identification in NAF, Serum, and Tissue in Women With Breast Cancer
Identifying the miR Fingerprint in NAF, Serum, and Tissue in Patients With Ductal Carcinoma in Situ (DCIS) or Invasive 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.

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.

Interventional
Phase 0
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Breast Cancer
  • Ductal Carcinoma in Situ
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
Experimental: Oxytocin
Subjects would receive 4 IU of intranasal oxytocin; one spray in each nostril, single-use.
Intervention: Drug: Intranasal Oxytocin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
March 2017
March 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Sheldon M Feldman, MD (212) 305-9676
United States
 
NCT02127073
AAAL5203
Yes
Sheldon Feldman, Columbia University
Sheldon Feldman
Not Provided
Principal Investigator: Sheldon Feldman, MD Columbia University
Columbia University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP