Evaluating efficacy of screening for upper gastrointestinal cancer in China: a study protocol for a randomized controlled trial

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摘要 Objective:Toevaluatetheefficacyandfeasibilityofscreeningprocedureforuppergastrointestinalcancerinbothhigh-riskandnon-high-riskareasinChina.Setting:Sevencities/counties,representingthreeeconomical-geographicalregions(Eastern,CentralandWestern)inChina,wereselectedasscreeningcenters:threeinhigh-riskareasandfourinnon-high-riskareas.Participants:Villages/communitiesinthesesevencentersregardedasclusterswererandomlyassignedtoeitherinterventiongroup(screeningbyendoscopicexamination)orcontrolgroup(withnormalcommunitycare)ina1:1ratiostratifiedbyeachcenter.Eligibleparticipantsarelocalresidentsaged40–69yearsintheselectedvillages/communitieswithnohistoryofcancerorendoscopicexaminationinthelatest3yearswhoarementallyandphysicallycompetent.Thosewhoarenotwillingtotakeendoscopicexaminationorareunwillingtosigntheconsentformareexcludedfromthestudy.Totally140,000participantswillbeenrolled.Interventions:Inhigh-riskareasofuppergastrointestinalcancer,allsubjectsinscreeninggroupwillbescreenedbyendoscopy.Innon-high-riskareas,30%ofthesubjectsinscreeninggroup,identifiedthroughasurvey,willbescreenedbyendoscopy.Primaryandsecondaryoutcomemeasures:Theprimaryoutcomeisthemortalitycausedbyuppergastrointestinalcancer.Thesecondaryoutcomesincludedetectionrate,incidencerate,survivalrate,andclinicalstagedistribution.Additionaldataonqualityoflifeandcost-effectivenesswillalsobecollectedtoanswerimportantquestionsregardingscreeningeffects.Conclusions:ScreeningstrategyevaluatedinthoseareaswithpositivefindingsmaybepromotednationallyandappliedtothemajorityofChinesepeople.Ontheotherhand,negativefindingswillprovidescientificevidenceforabandoningatestandshiftingresourceselsewhere.Trialregistration:ThestudyhasbeenregisteredwiththeProtocolRegistrationSysteminChineseClinicalTrialRegistry.
机构地区 不详
出版日期 2017年04月14日(中国期刊网平台首次上网日期,不代表论文的发表时间)
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