DETECTION OF MALIGNANT CELLS IN MARROW & PBPC FRACTIONS

本项目的具体目标是：1.确定可行性 检测骨髓和外周血祖细胞(PBPC) 在S9623上登记的乳腺癌患者的部分存在 2.确定对肿瘤细胞进行定量检测的可行性 应用骨髓和PBPC组分测定乳腺癌细胞含量 抗乳腺癌单抗和免疫细胞化学 逆转录聚合酶链式反应(RT-PCR)检测 细胞角蛋白-19；以及，3.确定肿瘤细胞的真实发生率 II/III期乳腺癌的造血组分污染 腋窝淋巴结4~9个。 我们的大部分初步乳腺癌检测数据都是在 新鲜骨髓和外周血细胞样本取自加州大学 科罗拉多州的乳腺癌患者。在未来两年里，目前的 研究将确定进行类似检测的可行性 对患者样本的研究连夜从许多 合作团体机构。如果这个可行性研究成功， 我们将能够确定乳腺癌的发病率 入选患者造血细胞组分的污染情况 在研究的头两年。然后我们将为两个人寻求资金 再花几年时间继续检测造血细胞样本 在S9623登记参加其余研究的患者，即 预计将在总共四年内增加患者。临床 结果，包括无病存活率以及地点和 复发的模式，将与乳腺癌的检测相关 化验结果。或者，如果我们不能成功地分析 从外部机构运来的标本，这样的额外资金 不会被追捕。肿瘤检测方法的主要方面 目前的可行性试点将解决的问题包括：评估 对连夜运送的标本进行的化验质量； 外部机构合规性的评估；真实情况的评估 乳腺癌在造血细胞分期中的发病率 II/III 4-9结节阳性乳腺癌患者；以及，将比较 免疫组织化学和分子检测对乳房的敏感性 癌症。

The specific aims of this project are: 1. To determine the feasibility of assaying the marrow and peripheral blood progenitor cell (PBPC) fractions of breast cancer patients enrolled on S9623 for the presence of malignant cells; 2. To determine the feasibility of quantitating the breast cancer cell content of the marrow and PBPC fractions using immunocytochemistry with anti-breast cancer monoclonal antibodies and reverse transcriptase polymerase chain reaction (RT-PCR) for cytokeratin-19; and, 3. To determine the true incidence of tumor cell contamination of hematopoietic fractions of Stage II/III breast cancer patients with 4-9 axillary lymph nodes. The bulk of our preliminary breast cancer detection data was generated with fresh marrow and PBPC specimens obtained from University of Colorado breast cancer patients. Over the next two years, the current study will determine the feasibility of conducting similar detection studies with patient specimens shipped overnight from the many cooperative group institutions. If this feasibility study is successful, we will be able to determine the incidence of breast cancer contamination in the hematopoietic cell fractions of patients enrolled in the first two years of the study. We will then seek funding for two additional years to continue to assay the hematopoietic cell specimens of patients enrolled on S9623 for the remainder of the study, which is projected to accrue patients for a total of four years. Clinical outcomes, including disease-free survival rates as well as sites and patterns of relapse, will be correlated with the breast cancer detection assay results. Alternatively, if we are unable to successfully assay the specimens shipped from outside institutions, such additional funding will not be sought. The major aspects of the tumor detection assays which the current feasibility pilot will address include: assessment of the quality of the assays performed on specimens shipped overnight; assessment of outside institution compliance; assessment of the true incidence of breast cancer in the hematopoietic cell fractions of Stage II/III 4-9 nod-positive breast cancer patients; and, will compare the sensitivity of the immunohistochemical and molecular assays for breast cancer.