TransValid-KFO179/GRCSG-Trial

TransValid-KFO179/ grcsg试验是一项多中心翻译生物标志物驱动的验证研究（验证研究，n=200例患者），结合一项高度创新的i /II期研究（可行性研究，n=50例患者），用于治疗可切除直肠癌患者（临床UICC II、III和IV期）。该试验与dfg资助的跨学科临床研究单位179 （Göttingen）直接相关（KFO179：“直肠癌患者个体肿瘤反应的生物学基础”），并将在KFO179的第二个资助期进行，从2011年3月开始，与德国直肠癌研究小组（GRCSG）的合格中心密切合作。TransValid-KFO179/GRCSG-Trial试验被认为是KFO179在第一个资助期（2007-2010年）研究的结果。预计在未来的GRCSG多中心试验中，基于验证的生物学参数集，它将对直肠癌的管理做出重大贡献。这些生物标志物集将基于微阵列表达特征、5-FU代谢单基因分析、凋亡和map -激酶途径的几个参数，并将来自对KFO179的深入研究。除了验证生物标志物外，TransValid-KFO179/ grcsg试验还解决了如何将具有高维数据的生物医学实验整合到日常临床环境中的问题。这些任务要求很高，迄今尚未在临床试验或治疗直肠癌患者的临床常规中完成。

The TransValid-KFO179/GRCSG-Trial is a multicenter translational biomarker-driven validation study (validation study, n=200 patients) combined with a highly innovative phase-I/II study (feasibility study, n=50 patients) for treatment of patients with resectable rectal cancer (clinical UICC stages II, III and IV). The trial is directly connected with the DFG–funded Interdisciplinary Clinical Research Unit 179 at Göttingen (KFO179: “Biological basis of individual tumor response in patients with rectal cancer”) and will be performed during the second funding period of the KFO179, starting in March 2011 in close cooperation with qualified centers of the German Rectal Cancer Study Group (GRCSG). The TransValid-KFO179/GRCSG-Trial trial is regarded as a result of the research of the KFO179 during the first funding period (2007-2010). It is expected to contribute significantly to the management of rectal cancer in future multicenter trials of the GRCSG, based on validated sets of biological parameters. These biomarker sets will be based on microarray expression signatures, analysis of single genes of 5-FU metabolism, several parameters of apoptosis and MAP-Kinase pathways and will be derived from thorough research of the KFO179. Beside the validation of biomarkers the TransValid-KFO179/GRCSG-Trial addresses questions of how to integrate biomedical experiments with high-dimensional data into clinical settings on a day-by-day basis. These tasks are demanding and have to date not been accomplished within clinical trials or clinical routine for treatment of rectal cancer patients.