Clinical Studies of Circulating Epithelial Cancer Cells

描述(由申请人提供)： 描述上皮循环癌细胞(CCC)的技术首先是在Cell Works的第一阶段研究中建立的。这项研究是以前列腺癌为基础的，并已扩大到包括乳腺癌、结肠癌、胃癌、肝癌和胰腺癌，对所有六种上皮性癌症采用相同的通用测试方案。实验室验证通过将培养的癌细胞添加到正常血液样本中证明了测试的可靠性和重复性，回收率通常在60%-80%之间。这项临床研究的目的是证明CCCT(BroudBiopsySM)在治疗转移性结肠癌和乳腺癌方面的临床应用。这些临床研究将与马里兰大学、退伍军人医学中心和罗斯威尔公园癌症中心合作进行。主要目的将是在已知的淋巴结阳性或转移性乳腺癌和结肠癌患者中，在治疗前确定细胞数量和阳性患者百分比，并在与治疗和肿瘤评估相一致的时间间隔确定细胞数量和阳性患者百分比。在NCI拨款提供的资金和时间限制内，我们打算尽可能地确定生物标记物和患者预后之间的任何趋势或相关性。此外，我们打算尽可能地确定循环细胞和患者预后之间的任何趋势或相关性。具体地说，治疗前和治疗后的细胞数量与患者预后之间是否存在关系？临床资料(转移部位、肿瘤负担程度、既往药物治疗和疾病进展)与CCCT结果(无论是阴性还是阳性)之间是否有关系？在这项为期3年的研究中，总共将对500名患者进行约1500项测试。这是第一项临床研究，寻找循环癌细胞和转移性癌症患者的临床数据之间的趋势或相关性。这也是第一项评估分离细胞上表达的特定生物标记物是否可以作为治疗指标来选择最容易从新的特定抗癌药物中受益的患者的研究。我们预计，这项研究的结果将证明CCCT作为未来抗癌新药临床试验的治疗指标的实用性。

DESCRIPTION (provided by applicant): Technology describing epithelial circulating cancer cells (CCC) was first established in Cell Works' Phase I study. This study was based on prostate cancer and has been expanded to include breast, colon, gastric, liver and pancreatic cancer with the same universal test protocol for all six epithelial cancers. Laboratory validation demonstrated the reliability and reproducibility of the tests by spiking cultured cancer cells into normal blood samples with a recovery rate typically in the range of 60-80%. The goal of this clinical study is to demonstrate the clinical utility of the CCCT (BloodBiopsySM) for the management of metastatic colon and breast cancer. These clinical studies will be done in collaboration with University of Maryland, VA Medical Center and Roswell Park Cancer Center. The primary aim will be to determine the numbers of cells and percent of patients positive prior to treatment and at intervals coincident with treatment and tumor assessment in known lymph node-positive or metastatic breast and colon cancer patients. Within the limitations of funds and time to be provided by this NCI grant, we intend to determine, to the extent possible, any trend or correlation between biomarkers and patient outcome. In addition, we intend to determine to the extent possible any trend or correlation between circulating cells and patient outcome. Specifically, is there a relationship between cell numbers before and after treatment and patient outcome? Is there a relationship between the clinical data (location of metastasis, degree of tumor burden, previous drug treatment and progression of disease) and CCCT results, both negative and positive? A total of about 1500 tests for 500 patients will be done within this 3-year study for these two cancers. This is the first clinical study searching for a trend or correlation between circulating cancer cells and the clinical data from patients with metastatic cancer. It is also the first study to assess whether specific biomarkers expressed on isolated cells can be used as therapeutic indicators to select patients who are most apt to benefit from new specific anticancer drugs. We anticipate that the outcome of this study will demonstrate the utility of the CCCT to serve as a therapeutic indicator for future clinical trials of new anticancer drugs.