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Could not identify collaborator and secure additional funding after transferring the record to Montefiore Medical Center
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin | Experimental | Subjects would receive 4 IU of intranasal oxytocin; one spray in each nostril, single-use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Oxytocin | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Detection of microRNA in NAF, Serum, or Tissue | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Collection of ≥ 5 μL of Nipple Aspirate Fluid | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheldon Feldman, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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The trial officially opened to enrollment in 2015 with first patient enrolled on 1/30/2015 at Columbia University Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With Detection of microRNA in NAF, Serum, or Tissue | 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. | Posted | 3 years |
|
|
From initiation of any study procedures to the end of the study treatment follow-up period at the Visit 2/End of Study visit, up to 4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sheldon Feldman, Chief Breast Surgery and Breast Surgery Oncology | Montefiore Medical Center | 929-246-6300 | sfeldman@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2016 | Oct 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Secondary | Percentage of Patients With Collection of ≥ 5 μL of Nipple Aspirate Fluid | 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. | Posted | 3 years |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |