DETECTION OF MALIGNANT CELLS IN MARROW & PBPC FRACTIONS

该项目的具体目标是：1。以确定可行性 分析骨髓和外周血祖细胞（PBPC） 入组S9623的乳腺癌患者的比例 恶性细胞; 2.确定量化的可行性 骨髓和PBPC组分的乳腺癌细胞含量， 用抗乳腺癌单克隆抗体进行免疫细胞化学， 逆转录聚合酶链反应（RT-PCR） 细胞角蛋白-19;和，3.确定肿瘤细胞的真实发生率 II/III期乳腺癌造血成分的污染 腋窝淋巴结4-9个。 我们的大部分初步乳腺癌检测数据是由 新鲜骨髓和PBPC标本， 科罗拉多乳腺癌患者。 在接下来的两年里，目前 研究将确定进行类似探测的可行性 研究中，患者样本连夜从许多 合作团体机构。如果可行性研究成功， 我们就能确定乳腺癌的发病率 入组患者的造血细胞组分中的污染 在研究的头两年。 然后我们将为两个项目寻求资金 额外的几年来继续分析造血细胞标本 的患者入组S9623进行剩余研究， 预计将在总共四年内增加病人。 临床 结果，包括无病生存率以及部位和 复发模式，将与乳腺癌检测相关 分析结果。 或者，如果我们不能成功地分析 从外部机构运来的标本，这种额外的资金 将不会被寻求。肿瘤检测分析的主要方面 目前的可行性试验将解决的问题包括： 对连夜运输的标本进行的检测的质量; 外部机构遵守情况评估; 乳腺癌的发病率在造血细胞部分的阶段 II/III型4-9例乳腺癌患者;以及，将比较 乳腺癌免疫组化和分子检测的敏感性 癌

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.