Table 14 Summary of studies of evaluating gene panel testing of tumours, with a view of treatment management or placing patients into early phase clinical trials Lead Citation type Country Diagnostic test Context/Study Date Test method(s) Use of archive Outcomes author/Year type tissue reported potentially relevant to this submission Tran 2011 Conference Canada Multi-platform Feasibility of 15 enrolled Not reported Targeted FFPE and snap Test failures abstract molecular prospective patients (14 mutation frozen; new and TATO profiling in molecular tested) analysis archive tissue TATRR patients with profiling of (Sequenom (preliminary Biopsy failure advanced solid tumours; 5 centre Mass Array); report) rate tumours study Targeted exome Biopsy adverse sequencing; events confirmed by Sanger sequencing Bedard 2013 Conference Canada Targeted gene Trial screening 485 patients Patients Next generation Exclusively Test failures abstract testing panel of program to match enrolled sequencing testing in various patients with between Mar archival FFPE advanced solid target therapies; 2012 – Jan tissue cancers Single institution 2013 Takahashi 2013 Conference Japan Pan-cancer Feasibility study 105 patients Patients Next generation FFPE tissues, Test failures abstract gene panel of multiplex enrolled sequencing mainly archive Biopsy adverse screening for screening; single between Jul events advanced solid centre 2012-Feb Re-biopsy rate tumours 2013 Yardley 2013 Conference US Cancer gene Community 101 samples Samples Next generation Exclusively Test failures abstract panel screening based molecular profiled sequencing testing in in metastatic profiling initiative between Oct archival FFPE breast cancer for identifying 2012 – May tissue candidates for 2013 targeted therapies Morris 2014 Conference US Cancer gene Feasibility study 400 cases Patients IHC, gene Not specified Test failures abstract panel screening of large scale enrolled sequencing, whether testing TATRS screening in between Aug was on newly
Table 14 Summary of studies of evaluating gene panel testing of tumours, with a view of treatment management or placing patients into early phase clinical trials Lead author/Year Citation type Country Diagnostic test Context/Study type Date Test method(s) Use of archive tissue Outcomes reported potentially relevant to this submission Tran 2011 Conference abstract Canada Multi-platform molecular profiling in patients with advanced solid tumours Feasibility of prospective molecular profiling of tumours; 5 centre study 15 enrolled patients (14 tested) (preliminary report) Not reported Targeted mutation analysis (Sequenom Mass Array); Targeted exome sequencing; confirmed by Sanger sequencing FFPE and snap frozen; new and archive tissue Test failures TATO TATRR Biopsy failure rate Biopsy adverse events Bedard 2013 Conference abstract Canada Targeted gene testing panel of various advanced solid cancers Trial screening program to match patients with target therapies; Single institution 485 patients Patients enrolled between Mar 2012 – Jan 2013 Next generation sequencing Exclusively testing in archival FFPE tissue Test failures Takahashi 2013 Conference abstract Japan Pan-cancer gene panel screening for advanced solid tumours Feasibility study of multiplex screening; single centre 105 patients Patients enrolled between Jul 2012-Feb 2013 Next generation sequencing FFPE tissues, mainly archive Test failures Biopsy adverse events Re-biopsy rate Yardley 2013 Conference abstract US Cancer gene panel screening in metastatic breast cancer Community based molecular profiling initiative for identifying candidates for targeted therapies 101 samples Samples profiled between Oct 2012 – May 2013 Next generation sequencing Exclusively testing in archival FFPE tissue Test failures Morris 2014 Conference abstract US Cancer gene panel screening Feasibility study of large scale screening in 400 cases Patients enrolled between Aug IHC, gene sequencing, Not specified whether testing was on newly Test failures TATRS
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