{"id":"hum0607","version":1,"url":"https://humandbs.dbcls.jp/research/hum0607/v1","datePublished":"2026-09-30","versions":[{"version":1,"datePublished":"2026-09-30"}],"title":{"ja":"「ALK遺伝子異常を有する希少がんに対するアレクチニブの医師主導治験」に附随するバイオマーカーの探索研究","en":"Exploratory Biomarker Study Associated with the Investigator-Initiated Clinical Trial of Alectinib for Rare Cancers Harboring ALK Alterations"},"summary":{"aims":{"ja":"ALK遺伝子異常を有する希少がんに対するアレクチニブの医師主導治験に登録され、アレクチニブ治療が行われた症例において、治験治療前後に採取された検体（腫瘍組織と末梢血）や末梢血循環腫瘍細胞 (Circulating Tumor Cell：CTC) のオミクス解析等を行い、アレクチニブ治療の臨床効果と関連するバイオマーカーを同定する。","en":"To identify biomarkers associated with the clinical efficacy of alectinib treatment by performing omics analyses of specimens, including tumor tissue and peripheral blood samples collected before and after investigational treatment, as well as circulating tumor cells (CTCs), from patients with rare cancers harboring ALK gene alterations who were enrolled in an investigator-initiated clinical trial of alectinib and received alectinib treatment."},"methods":{"ja":"Target Capture Sequencing解析","en":"Target sequencing"},"targets":{"ja":"アレクチニブの医師主導治験に登録されたALK遺伝子異常を有する希少がん24症例の血漿中cell free DNA 24検体、内19症例のバフィーコートより抽出したDNA 19検体","en":"cfDNA in 24 plasma samples obtained from 24 patients enrolled in an investigator-initiated clinical trial of alectinib for rare cancers harboring ALK alterations, and gDNA extracted from buffy coats from 19 of these patients."},"url":{"ja":null,"en":null}},"listingSummary":{"methods":{"ja":"配列決定","en":"Sequencing"},"targets":{"ja":"ALK遺伝子異常を有する希少癌：24症例\n（日本人）","en":"Rare cancers harboring ALK alterations: 24 cases\n(Japanese)"},"typeOfData":{"ja":"NGS\n（Target capture）","en":"NGS\n(Target capture)"}},"releaseNote":{"ja":"ALK遺伝子異常を有する希少がん24症例の血漿中cfDNA 24検体およびバフィーコートより抽出したDNA 19検体を用いた737個のがん関連遺伝子のTarget Capture Sequencing解析データをbamファイルにて提供する。","en":"Cell-free DNA in 24 plasma samples from 24 rare cancers harboring ALK alterations and DNA extracted from buffy coat samples from 19 of these patients were used for the target capture sequencing analysis about 737 genes related to cancer. Bam files are provided."},"dataProviders":[{"name":{"ja":"高阪 真路","en":"Shinji Kohsaka"},"organization":{"name":{"ja":"国立がん研究センター 研究所細胞情報学分野","en":"Division of Cellular Signaling, National Cancer Center Research Institute"}}}],"researchProjects":[{"name":{"ja":"TACKLE試験附随研究","en":"TACKLE trial translational research"},"url":{"ja":null,"en":null}}],"grants":[{"title":{"ja":"先端技術を用いたクリニカルシークエンスの開発と稼働性・臨床的有用性の検証研究","en":"Development of Clinical Sequencing Using Advanced Technologies and Validation of Its Feasibility and Clinical Utility"},"agency":{"ja":"がんセンター研究開発費","en":"NCC Research Grant"},"grantIds":["2025-A-04"]}],"relatedPublications":[{"title":"Efficacy and Safety of Alectinib in Pediatric and Adult Patients with ALK-Altered Advanced Solid Tumors: a phase II TACKLE Trial (NCCH1712/MK003)","datasets":["JGAD001104"]}],"datasets":["JGAD001104"],"controlledAccessUsers":[]}