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临床试验/NCT00407706
NCT00407706Unknown不适用

Breast Cancer- Early Detection of Cancer Disease and Pre-Cancer Disease, and in Women That Are at High Risk for Developing Breast Cancer by Identifying Lymphocytes Previously Exposed to Specific Cancer Antigen.

Ziv Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2006年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
180
试验地点
1

研究概览

简要总结

In our previous research, we have shown that women that have breast cancer have a population of lymphocytes that recognizes specific antigen and there cytoplasmic matrix goes through physical change a short time after exposure in vitro to the same antigen. This change can be measured by polarization changes of fluorescent light emitted by FDA (fluorescein diacetate) labeled cells. Further test that we performed showed that those differences are also shown in a benign situation that known as indicator for a high risk for developing breast cancer within 10-15 years. The incidence of the expression of these lymphocytes correlates with the histopathological picture as it is related in high risk for the developing the disease.

In this work we will expand the scope of the procedure to early detection of the cancerous process in breast lesions by Fitzgibbon's risk categories for the development invasive carcinoma of the breast. In the proposed work we intend to use specific antigen MUC1 for breast cancer. This study is a continuation of our published work in the "The Breast "

研究设计

研究类型
Observational
观察模型
Defined Population
时间视角
Other

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women carrying benign breast lesions will be further divided and analyzed according to the Fitzgibbon's risk categories for invasive cancer risk (4). The Fitzgibbon's categories are:
  • No increased risk group including adenosis (other than sclerotic), duct ectasia fibroadenoma without complex features,
  • slightly increased risk group (1.5-20 times) which includes fibroadenoma with complex features, moderate or florid hyperplasia without atypia, sclerosing adenosis,
  • moderately increased risk group (4.0-5.0 times) includes atypical ductal and lobular hyperplasia and
  • markedly increased risk group (8.0-10.0 times) which includes ductal and lobular carcinomas In Situ Following the blood collection, detailed relevant clinical information of the patient will be registered in a case record form.
  • The data will include: age, country of birth, last menstrual period, lactation, number of children, age at first full-term pregnancy, age at onset of menopause, family history, medication, mammography findings, FNA results, tumor size, histological findings, biopsies, disease staging, and other relevant clinical information.

排除标准

  • experiencing menstruation, or
  • under hormonal or drug treatment.

研究者

发起方
Ziv Hospital
申办方类型
Other Gov

研究点 (1)

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