Breast Cancer, Ductal Carcinoma in Situ
Conditions
Keywords
Breast cancer, Ductal carcinoma in situ (DCIS), Oxytocin
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.
Interventions
DRUGIntranasal 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
Sponsors
Montefiore Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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 Oxytocin in the past
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Patients With Detection of microRNA in NAF, Serum, or Tissue | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Patients With Collection of ≥ 5 μL of Nipple Aspirate Fluid | 3 years |
Countries
United States
Participant flow
Recruitment details
The trial officially opened to enrollment in 2015 with first patient enrolled on 1/30/2015 at Columbia University Medical Center.
Participants by arm
| Arm | Count |
|---|---|
| Oxytocin Subjects would receive 4 IU of intranasal oxytocin; one spray in each nostril, single-use.
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 | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Oxytocin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Percentage of Patients With Detection of microRNA in NAF, Serum, or Tissue
Time frame: 3 years
Population: The study was voluntarily suspended as documented in IND Annual Report (Serial Number 0007). Data was not collected/aggregated and no interim analyses were conducted.
Secondary
Percentage of Patients With Collection of ≥ 5 μL of Nipple Aspirate Fluid
Time frame: 3 years
Population: The study was voluntarily suspended as documented in IND Annual Report (Serial Number 0007). Data was not collected/aggregated and no interim analyses were conducted.