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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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Ductal Carcinoma in Situ
Drug: Intranasal Oxytocin
Phase 0

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Percentage of patients with detection of microRNA in NAF, serum, or tissue [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with collection of ≥ 5 μL of nipple aspirate fluid [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxytocin
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02127073

Contacts
Contact: Sheldon M Feldman, MD (212) 305-9676

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Sheldon M Feldman, MD    212-305-9676      
Principal Investigator: Sheldon M Feldman, MD         
Sponsors and Collaborators
Sheldon Feldman
Investigators
Principal Investigator: Sheldon Feldman, MD Columbia University
  More Information

No publications provided

Responsible Party: Sheldon Feldman, Vivian L. Milstein Associate Professor of Clinical Surgery, Columbia University
ClinicalTrials.gov Identifier: NCT02127073     History of Changes
Other Study ID Numbers: AAAL5203
Study First Received: April 28, 2014
Last Updated: May 10, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Columbia University:
Breast cancer
Ductal carcinoma in situ (DCIS)
Oxytocin

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Adenocarcinoma
Breast Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Glandular and Epithelial
Skin Diseases
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014