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中文摘要
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这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者(PI)可能从另一个NIH来源获得了主要资金, 因此可以在其他CRISP条目中表示。所列机构为 中心,不一定是研究者的机构。 这是一项研究局部晚期乳腺癌(LABC)的方案,目的是了解癌症从局部疾病到转移的进展。 将研究LABC,以确定对同时进行的紫杉醇和放射有反应的疾病是否在遗传、免疫学或分子学上与无反应并进展为转移性疾病的疾病不同。 这项研究将广泛研究该疾病的行为、文化、流行病学(包括风险因素)、遗传、免疫、分子和(可能)种族方面。 将招募300名患者,其中100名来自纽约大学,其他来自南非和墨西哥。 将采集入组试验的个体的样本,用于诊断和后续病理学、基因组学和分子生物学目的。 标本采集和储存需征得同意,以备后续使用。 该研究的动机是观察到对原发性化疗的病理学反应正在成为生存的替代终点。 LABC提供了一个很好的机会来研究疾病进展到转移的生物学相关性,因为在LABC中记录了细胞脱落到循环中,但这不足以引发远端疾病的发展。 局部肿瘤对化疗和放疗反应的研究有望帮助评估针对肿瘤特征的后续治疗。 LABC是一种“服务不足的疾病”,弱势群体可能会推迟寻求(或找到)帮助,直到疾病进展。 这项研究的国际网站提供了进入属于这一类别的人群,并允许研究疾病的广泛潜在因素。 肿瘤和周围组织的分子和遗传特征将有望为研究细胞群的转化提供机会。 流行病学和文化信息将有助于制定适合不同人群的诊断和治疗战略。
英文摘要
This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a protocol studying locally advanced breast cancer (LABC) with the goal of understanding the progression of cancer from local disease to metastasis. LABC will be studied to see whether disease that responds to concurrent Paclitaxel and radiation is genetically, immunologically or molecularly distinct from that which is unresponsive and progresses to metastatic disease. The study will broadly study behavioral, cultural, epidemiological (including risk factors), genetic, immunological, molecular and (possibly) ethnic aspects of the disease. Three hundred patients will be enrolled, 100 at NYU and others in South Africa and Mexico. Individuals enrolled in the trial will have samples collected that will be used for both diagnostic and subsequent pathological, genomic and molecular biological purposes. Consent is requested for specimen collection and banking for subsequent use. The study is motivated by the observation that the pathological response to primary chemotherapy is emerging as a surrogate endpoint for survival. LABC provides a good opportunity to study the biological correlates of disease progression to metastasis, since shedding of cells into the circulation is documented in LABC, but this is not sufficient to trigger the development of remote disease. A study of the response of the local tumor to chemotherapy and radiation is expected to help evaluate subsequent treatment tailored to the tumor characteristics. LABC is a "disease of the underserved," with disadvantaged individuals likely to delay seeking (or finding access to) help until the disease has progressed. International sites for this study provide access to populations that fall into this category and permit a broad range of potential factors in the disease to be studied. The molecular and genetic profiles of the tumors and surrounding tissues will hopefully provide a chance to study the transformation of the cell populations. Epidemiological and cultural information will permit diagnosis and treatment strategies appropriate for different populations.
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