Back to results

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

Primary Purpose

Breast Cancer, Ductal Carcinoma in Situ

Status

Suspended

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Intranasal Oxytocin

About this trial

This is an interventional basic science trial for Breast Cancer focused on measuring Breast cancer, Ductal carcinoma in situ (DCIS), Oxytocin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Columbia University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oxytocin

Arm Description

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

Outcomes

Primary Outcome Measures

Percentage of patients with detection of microRNA in NAF, serum, or tissue

Secondary Outcome Measures

Percentage of patients with collection of ≥ 5 μL of nipple aspirate fluid

Full Information

NCT ID

NCT02127073

First Posted

April 28, 2014

Last Updated

August 3, 2023

Sponsor

Sheldon Feldman

1. Study Identification

Unique Protocol Identification Number

NCT02127073

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Suspended

Why Stopped

Study suspended by Columbia University IRB. Needs funding and scientific collaborator

Study Start Date

March 2014 (undefined)

Primary Completion Date

March 2027 (Anticipated)

Study Completion Date

March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sheldon Feldman

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Ductal Carcinoma in Situ

Keywords

Breast cancer, Ductal carcinoma in situ (DCIS), Oxytocin

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oxytocin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Intranasal Oxytocin

Other Intervention Name(s)

Syntocinon Spray

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of patients with detection of microRNA in NAF, serum, or tissue

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Percentage of patients with collection of ≥ 5 μL of nipple aspirate fluid

Time Frame

3 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 Oxytocyn in the past

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sheldon Feldman, MD

Organizational Affiliation

Montefiore Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs