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

Phase 2

Terminated

• Conditions: Breast Cancer; Ductal Carcinoma in Situ
• Interventions: Drug: Intranasal Oxytocin

• Registration Number: NCT02127073
• Lead Sponsor: Montefiore Medical Center

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.

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 Timeline

• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-30
• Study Start: 2015-01-30
• Primary Completion: 2017-01-18
• Study Completion: 2017-09-18
• Results First Submitted: 2023-10-16
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-07
• Last Update Submitted: 2023-11-07
• Results First Posted: 2023-11-09
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxytocin	Intranasal Oxytocin	Subjects would receive 4 IU of intranasal oxytocin; one spray in each nostril, single-use.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Detection of microRNA in NAF, Serum, or Tissue	3 years

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Collection of ≥ 5 μL of Nipple Aspirate Fluid	3 years

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States