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

Sponsor
Sheldon Feldman (Other)
Overall Status
Suspended
CT.gov ID
NCT02127073
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
156
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intranasal Oxytocin
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
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
Study Start Date :
Mar 1, 2014
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Mar 1, 2027

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of patients with detection of microRNA in NAF, serum, or tissue [3 years]

    Secondary Outcome Measures

    1. Percentage of patients with collection of ≥ 5 μL of nipple aspirate fluid [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Columbia University Medical Center New York New York United States 10032

    Sponsors and Collaborators

    • Sheldon Feldman

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sheldon Feldman, Chief Division of Breast Surgery and Breast Surgical Oncology, Director Breast Cancer Services, Montefiore Medical Center
    ClinicalTrials.gov Identifier:
    NCT02127073
    Other Study ID Numbers:
    • AAAL5203
    First Posted:
    Apr 30, 2014
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Sheldon Feldman, Chief Division of Breast Surgery and Breast Surgical Oncology, Director Breast Cancer Services, 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
    Oxytocin

    Study Results

    No Results Posted as of Jul 29, 2022