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

Breast Cancer Clinical Trial

Official title:

Identifying the miR Fingerprint in NAF, Serum, and Tissue in Patients With Ductal Carcinoma in Situ (DCIS) or Invasive Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02127073
• Other study ID #: AAAL5203
• Status: Terminated
• Phase: Phase 2
• Start date: January 30, 2015
• Est. completion date: September 18, 2017

Study information

• Verified date: November 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 18, 2017
• Est. primary completion date: January 18, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma in Situ

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Detection of microRNA in NAF, Serum, or Tissue		3 years
Secondary	Percentage of Patients With Collection of = 5 µL of Nipple Aspirate Fluid		3 years