Clinical Studies of Circulating Epithelial Cancer Cells

循环上皮癌细胞的临床研究

• 批准号: 6656748
• 负责人: PAUL O. P. TS'O
• 金额: $ 32.01万
• 依托单位: CCC DIAGNOSTICS, LLC
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-05-01 至 2004-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6656748
• 关键词: antineoplastics; biomarker; breast neoplasms; cell sorting; circulating neoplastic cell; clinical research; colon neoplasms; flow cytometry; fluorescent dye /probe; human subject; leukapheresis; leukocytes; liver neoplasms; micromanipulator; monoclonal antibody; prognosis; prostate neoplasms; stomach neoplasms; technology /technique development; tissue /cell culture

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.

描述（由申请人提供）： 描述上皮循环癌细胞 (CCC) 的技术最初是在 Cell Works 的 I 期研究中建立的。这项研究以前列腺癌为基础，现已扩展到包括乳腺癌、结肠癌、胃癌、肝癌和胰腺癌，并对所有六种上皮癌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掺入正常血液样本中来证明测试的可靠性和可重复性，回收率通常在 60-80% 范围内。本临床研究的目的是证明 CCCT (BloodBiopsySM) 在治疗转移性结肠癌和乳腺癌方面的临床实用性。这些临床研究将与马里兰大学、退伍军人管理局医疗中心和罗斯威尔公园癌症中心合作完成。主要目的是确定治疗前以及已知淋巴结阳性或转移性乳腺癌和结肠癌患者的治疗和肿瘤评估期间的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，我们打算尽可能确定生物标志物与患者结果之间的任何趋势或相关性。此外，我们打算尽可能确定循环细胞与患者结果之间的任何趋势或相关性。具体来说，治疗前后的细胞数量与患者结果之间是否存在关系？临床数据（转移位置、肿瘤负荷程度、既往药物治疗和疾病进展）与 CCCT 结果（阴性和阳性）之间是否存在关系？这项为期 3 年的研究将针对这两种癌症对 500 名患者进行总共约 1500 次测试。这是第一项寻找循环癌细胞与转移性癌症患者的临床数据之间的趋势或相关性的临床研究。这也是第一项评估分离细胞上表达的特定生物标志物是否可以用作治疗指标来选择最有可能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 作为未来新抗癌药物临床试验的治疗指标的实用性。