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1、CCA-11920;NoofPages14ClinicaChimicaActaxxx(2010)xxx–xxxContentslistsavailableatScienceDirectClinicaChimicaActajournalhomepage:www.elsevier.com/locate/clinchimInvitedcriticalreviewCell-freeDNAinthebloodasasolidtumorbiomarker—Acriticalappraisaloftheliteraturea,b,⁎,MichaelFleischhackercaKlausJu
2、ng,AnjaRabienaDepartmentofUrology,ResearchDivision,UniversityHospitalCharité,Schumannstr.20/21,10117Berlin,GermanybBerlinInstituteforUrologicResearch,10117Berlin,GermanycDepartmentofOncologyandHematology,UniversityHospitalCharité,Schumannstr.20/21,10117Berlin,GermanyarticleinfoabstractArticl
3、ehistory:Circulatingcell-freeDNA(cfDNA)hasbeensuggestedasacancerbiomarker.SeveralstudiesassessedtheReceived25June2010usefulnessofquantitativeandqualitativetumor-specificalterationsofcfDNA,suchasDNAstrandintegrity,Receivedinrevisedform24July2010frequencyofmutations,abnormalitiesofmicrosatellit
4、es,andmethylationofgenes,asdiagnostic,prognostic,Accepted25July2010andmonitoringmarkersincancerpatients.MostofthepapersthatcouldbeevaluatedinthisreviewresultedinAvailableonlinexxxxapositiveconclusion.However,methodicaldiversitywithoutthetraceabilityofdataanddifferentlydesignedandoftenunderpo
5、weredstudiesresultedindivergentresultsbetweenstudies.Inaddition,thelimitedKeywords:Circulatingcell-freeDNAdiagnosticsensitivityandspecificityofcfDNAalterationstempertheeffusivehopeofnoveltumormarkers,Solidcancerraisingsimilarissuesasthoseforothertumormarkers.Tovalidatetheactualclinicalvalidit
6、yofvariouscfDNAMutationsalterationsaspotentialcancerbiomarkersinpracticeforindividualtumortypes,themainproblemsoftheMicrosatellitesobserveduncertaintiesmustbeconsideredinfuturestudies.TheseincludemethodicalharmonizationMethylationmarkerconcerningsamplecollection,processing,andanalysiswiththe
7、traceabilityofmeasurementresultsaswellasGenometastasishypothesistherealizationofwell-designedprospectivestudiesbasedonpoweranalysisandsamplesizecalculations.©2010ElsevierB.V.Allrightsreserved.Contents1.Introduction..................................
