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

November 7, 2023 updated by: Montefiore Medical Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Oxytocin in the past

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Syntocinon Spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Patients With Detection of microRNA in NAF, Serum, or Tissue
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Patients With Collection of ≥ 5 μL of Nipple Aspirate Fluid
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Sheldon Feldman, MD, Montefiore Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2015

Primary Completion (Actual)

January 18, 2017

Study Completion (Actual)

September 18, 2017

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimated)

April 30, 2014

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAL5203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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