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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.
Verified February 2017 by Sheldon Feldman, Montefiore Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02127073
First Posted: April 30, 2014
Last Update Posted: February 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sheldon Feldman, Montefiore Medical Center
  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 Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Sheldon Feldman, Montefiore Medical Center:

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

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

Estimated Enrollment: 40
Study Start Date: March 2014
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
  • Prior Breast Cancer diagnosis
  • Adverse reaction to Oxytocyn in the past
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sheldon Feldman, Vivian L. Milstein Associate Professor of Clinical Surgery, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02127073     History of Changes
Other Study ID Numbers: AAAL5203
First Submitted: April 28, 2014
First Posted: April 30, 2014
Last Update Posted: February 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sheldon Feldman, Montefiore Medical Center:
Breast cancer
Ductal carcinoma in situ (DCIS)
Oxytocin

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


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