跳至主要内容
临床试验/NCT02127073
NCT02127073终止2 期

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

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2015年1月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
8
试验地点
1
主要终点
Percentage of Patients With Detection of microRNA in NAF, Serum, or Tissue

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Clinical diagnosis of Ductal carcinoma in situ (DCIS) or invasive breast cancer
  • Candidate for breast conserving surgery or mastectomy

排除标准

  • Pregnant women
  • Prior Breast Cancer diagnosis
  • Adverse reaction to Oxytocin in the past

研究组 & 干预措施

Oxytocin

Experimental

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

干预措施: Intranasal Oxytocin (Drug)

结局指标

主要结局

Percentage of Patients With Detection of microRNA in NAF, Serum, or Tissue

时间窗: 3 years

次要结局

  • Percentage of Patients With Collection of ≥ 5 μL of Nipple Aspirate Fluid(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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