Pilot Study of Oxytocin and microRNA Identification in NAF, Serum, and Tissue in Women With Breast Cancer
| Status: | Suspended |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/26/2018 |
| Start Date: | March 2014 |
| End Date: | March 2019 |
Identifying the miR Fingerprint in NAF, Serum, and Tissue in Patients With Ductal Carcinoma in Situ (DCIS) or Invasive Breast Cancer
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.
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.
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.
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.
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
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Sheldon M Feldman, MD
Phone: 212-305-9676
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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