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

NCT ID: NCT02127073

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-30
• Study Completion Date: 2017-09-18

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.

Conditions

Breast Cancer; Ductal Carcinoma in Situ

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Oxytocin

Subjects would receive 4 IU of intranasal oxytocin; one spray in each nostril, single-use.

Group Type: EXPERIMENTAL

Intranasal Oxytocin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Syntocinon Spray

Eligibility 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 Oxytocin in the past

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheldon Feldman, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAAL5203

Identifier Type: -

Identifier Source: org_study_id