Protocol

RB Approval # H24-132
Title Predictive Biomarkers in Stage II/III Gastric Cancer for Adjuvant Chemotherapy (NJBMR) by the Northern Japan Gastric Cancer Study Consortium
First Approval Oct 4, 2012
Period Oct 4, 2012〜Mar 31, 2014
Update Approval Jun 11, 2013
PI Satoshi Nishizuka, M.D., Ph.D.
Recruit None
Protocol docs Protocol_NJBiomarkerResearch_sn_08232016.pdf
IC docs Protocol_NJBiomarkerResearch_sn_08232016.pdf
Opt-out docs Yes
Approval docs H24-132_20130611.pdf
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RB Approval # HGH28-85(General)
Title Evaluation of minimal residual disease of colorectal cancer by ctDNA mutated gene monitoring (tent.)
First Approval Sep 1, 2016
Period Sep 1, 2016〜Dec, 2020
Update Approval Apr 17, 2020
PI Mizunori Yaegashi, M.D., Ph.D.
Recruit Active
Protocol docs HGH28-85研究計画書_ver1.55_clean.pdf
IC docs H28-85_HGH28-15_同意書_v1.55_10012020.pdf
Opt-out docs Yes
Approval docs H28-85_20200417.pdf
Status Active

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RB Approval # HGH28-15
Title Evaluation of minimal residual disease of colorectal cancer by ctDNA mutated gene monitoring (tent.)
First Approval Sep 15, 2016
Period Sep 15, 2016〜Dec, 2020
Update Approval Dec 7, 2020
PI Mizunori Yaegashi, M.D., Ph.D.
Recruit Active
Protocol docs HGH28-85研究計画書_ver1.55_clean.pdf
IC docs H28-85_HGH28-15_同意書_v1.55_10012020.pdf
Opt-out docs Yes
Approval docs HGH28-85_20201207.pdf
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RB Approval # HGH28-16
Title Validation of minimal residual disease of gastric cancer using circulating tumor DNA (tent.)
First Approval Sep 15, 2016
Period Sep 1, 2016〜Feb 29, 2020
Update Approval Apr 17, 2020
PI Satoshi Nishizuka, M.D., Ph.D.
Recruit None
Protocol docs HGH28-16_計画書_v2.0.pdf,
IC docs HGH28-16_同意書_v2.0.pdf
Opt-out docs Yes
Approval docs 倫理審査結果通知書_HGH28-16_04172020.pdf
Status Active

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RB Approval # HGH28-13
Title Information-based personalized medicine using artificial intelligence (tent.)
First Approval Sep 21, 2016
Period Sep 8, 2016〜Mar 31, 2020
Update Approval Dec 3, 2019
PI Satoshi Nishizuka, M.D., Ph.D. (Iwate Medical University), Satoru Miyano, Ph.D. (University of Tokyo)
Recruit Active
Protocol docs HGH28-13_倫理申請書_09212019.pdf
IC docs HGH28-13_説明書_09212019.pdf
Opt-out docs None
Approval docs HGH28-13_20191203.pdf
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RB Approval # HGH28-14
Title Genetic analysis of rare, refractory, and pediatric tumors for personalized medicine (tent.)
First Approval Sep 21, 2016
Period Sep 8, 2016〜Mar 31, 2020
Update Approval Dec 3, 2019
PI Satoshi Nishizuka, M.D., Ph.D., Yoichi Furukawa, M.D., Ph.D.
Recruit Active
Protocol docs HGH28-14_倫理申請書_09212019.pdf
IC docs HGH28-14_説明書_09212019.pdf
Opt-out docs None
Approval docs HGH28-14_20191203.pdf
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RB Approval # MH2018-019
Title Analysis of preferable effect from H. pylori infection for human health (with Daiko data from J-MICC cohort study)
First Approval Mar 21, 2018
Period May 21, 2018〜Mar 31, 2019
Update Approval Nov 20, 2019
PI Satoshi Nishizuka, M.D., Ph.D.
Recruit None
Protocol docs MH2018-019_計画書_v1.1.pdf
IC docs MH2018-019_計画書_v1.1.pdf
Opt-out docs None
Approval docs MH2018-019_20180521.pdf
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RB Approval # HG2019-001
Title Circulating tumor DNA monitoring in blood and urine in post-operative upper urothelial tract cancer
First Approval Apr 12, 2019
Period Apr 12, 2019〜Mar 31, 2022
Update Approval Apr 28, 2020
PI Daichi Tamura, M.D.
Recruit Active
Protocol docs 上部尿路上皮癌研究計画書2.1版20200730.pdf
IC docs 上部尿路上皮癌研究計画書2.1版20200730.pdf
Opt-out docs Yes
Approval docs 上部尿路上皮癌研究承認通知20200828.pdf
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RB Approval # HG2019-003
Title Monitoring Recurrence of Individual tumor by serial Observation of Known gene Alterations: MORIOKA study
First Approval May 29, 2019
Period May 29, 2019〜May 28, 2023
Update Approval Sep 27, 2021
PI Satoshi Nishizuka, M.D., Ph.D.
Recruit Active
Protocol docs HG2019-003_研究計画書_ver3.4_05252021a.pdf
IC docs HG2019-003_患者説明書・同意書_ver3.4_05252021a.pdf
Opt-out docs Yes
Approval docs HG2019-003_20210927.pdf
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RB Approval # HG2019-015
Title A pilot study for tumor burden monitoring using ctDNA in unresectable HCC
First Approval Aug 15, 2019
Period Aug 15, 2019〜Mar 31, 2022
Update Approval Aug 15, 2019
PI Yuji Suzuki, M.D., Ph.D.
Recruit Active
Protocol docs Y.S.研究計画書.pdf
IC docs Y.S.研究計画書.pdf
Opt-out docs None
Approval docs Y.S. 倫理審査結果通知者.pdf
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RB Approval # HG2019-030
Title Evaluation of clinical validity of circulating tumor DNA monitoring in post-treatment bladder cancer
First Approval Jun 2, 2020
Period June 2, 2020〜March 31, 2023
Update Approval Oct 26, 2021
PI Masakazu Abe, M.D.(Iwate Medical University)
Recruit Active
Protocol docs HG2019-030_Ver2.2_研究計画書_210814_ma_sn_ma.pdf
IC docs HG2019-030_Ver2.3_同意書_2020924_ma.pdf
Opt-out docs HG2019-030_情報公開文書_211018_ma.pdf
Approval docs HG2019-030_20211026.pdf
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RB Approval # HG2020-018
Title Predictive Biomarkers in Stage II/III Gastric Cancer for Adjuvant Chemotherapy (NJBMR) by the Northern Japan Gastric Cancer Study Consortium
First Approval Sep 7, 2020
Period Aug 31, 2020〜March 31, 2023
Update Approval Sep 7, 2020
PI Satoshi Nishizuka, M.D., Ph.D.
Recruit None
Protocol docs 研究計画書_Ver12.pdf
IC docs 研究計画書_Ver12.pdf
Opt-out docs Yes
Approval docs HG2020-018_20200907.pdf
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RB Approval # HG2020-021
Title Efficacy prediction of chemotherapy for ESCC using early-phase circulating tumor DNA dynamics
First Approval Nov 19, 2020
Period Nov 19, 2020〜Oct 31, 2021
Update Approval Nov 19, 2020
PI Takeshi Iwaya, M.D., Ph.D.
Recruit None
Protocol docs HG2020-021_ctDNAの初期変動を用いた化学療法効果予測_研究計画書v1.2-1.pdf
IC docs HG2020-021_ctDNAの初期変動を用いた化学療法効果予測_研究計画書v1.2-1.pdf
Opt-out docs None
Approval docs HG2020-021 Circulating tumor DNAの初期変動を用いた.pdf
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RB Approval # HG2020-027
Title Validation of quantitative ability of digital PCR using an “Off-The-Shelf” probe library to monitor frequently-mutated genes: the OTS-155 study
First Approval Dec 17, 2020
Period Dec 17, 2020〜Sep 30, 2022
Update Approval Jun 2, 2022
PI Satoshi S. Nishizuka, M.D., Ph.D.
Recruit Active
Protocol docs 研究計画書_OTS_EN2_210401_2.pdf
IC docs 説明文書_OTS_EN2_210401_3.pdf
Opt-out docs 情報公開文書_220525_forHP.pdf
Approval docs HG2020-027_20220602.pdf
Status Active

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RB Approval # HG2020-028
Title Genetic analysis in rare and refractory tumors for personalized medicine.
First Approval Dec 17, 2020
Period Dec 17, 2020〜Sep 30, 2023
Update Approval Jan 5, 2021
PI Satoshi Nishizuka, M.D., Ph.D., Yoichi Furukawa, M.D., Ph.D.
Recruit Active
Protocol docs 医科研難治性腫瘍研究倫理審査申請書20200918提出版_sn_12242020.pdf
IC docs 個別化医療_説明書_sn_12242020.pdf
Opt-out docs None
Approval docs HG2020-028_20210105.pdf
Status Active

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RB Approval # MH2021-073
Title Feasibility of CT scan reduction in postoperative surveillance of colorectal cancer patients using circulating tumor DNA
First Approval Aug 4, 2021
Period Aug 4, 2021~March 31, 2022
Update Approval Aug 4, 2021
PI Takeshi Iwaya, M.D., Ph.D.
Recruit Active
Protocol docs 研究計画書_ctDNAを用いた大腸癌術後サーベイランス_7.21.pdf 大腸癌ctDNA術後サーベイランス手順書_添付資料.pdf
IC docs 研究計画書_ctDNAを用いた大腸癌術後サーベイランス_7.21.pdf
Opt-out docs 情報公開文書_ctDNAを用いた大腸癌術後サーベイランス_7.21.pdf
Approval docs MH2021-073_20210804.pdf
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RB Approval # HG2021-018
Title Analysis of human cancer-related genes using OncomineTM
First Approval Sep 1, 2021
Period Sep 1, 2021~Jul 31, 2023
Update Approval Sep 1, 2021
PI Satoshi Nishizuka, M.D., Ph.D., Hitoshi Adachi
Recruit Active
Protocol docs 研究計画書_TFS_08262021.pdf
IC docs 研究計画書_TFS_08262021.pdf
Opt-out docs 情報公開文書_TFS_08232021.pdf
Approval docs MH2021-018_20210901.pdf
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RB Approval # MH2021-139
Title Management of advanced esophageal cancer patients received chemotherapy using early ctDNA dynamics: CHANGE-ES01 study
First Approval Jan 4, 2022
Period an 4, 2022~Jan 31, 2027
Update Approval Jan 4, 2022
PI Satoshi Nishizuka, M.D., Ph.D.
Recruit Active
Protocol docs 〇CHANGE_ES01_研究計画書Ver1.1_Iwaya.pdf
IC docs 〇CHANGE_ES01_患者説明書_Ver1.1_Iwaya.pdf
Opt-out docs None
Approval docs MH2021-139_20220104.pdf
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RB Approval # MH2021-140
Title Verification of DNA quality by long-term storage of FFPE blocks in autopsy cases
First Approval Jan 4, 2022
Period Jan 11, 2022~Dec 31, 2022
Update Approval Jan 4, 2022
PI Akiko Yashima-Abo, M.D., Ph.D.
Recruit Active
Protocol docs MH2021-140研究計画書第1.2版.pdf
IC docs MH2021-140研究計画書第1.2版.pdf
Opt-out docs MH2021-140オプトアウト第1.2版.pdf
Approval docs MH2021-140_20220104.pdf
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RB Approval # MH2021-180
Title Analysis of circulating tumor-derived DNA allele frequency in blood of long-term relapse-free patients after treatment for advanced cancer-01 study (ACTIVE LONG-01 study)
First Approval Feb 14, 2022
Period Feb 28, 2022~March 31, 2023
Update Approval Feb 22, 2022
PI Akiko Yashima-Abo, M.D., Ph.D.
Recruit Active
Protocol docs 研究実施計画書ACTIVE LONG study Version1.2 (MH2021-180).pdf
IC docs ACTIVE LONG study 説明書・同意書 進行がん治療後長期間無再発症例の血中腫瘍DNAアリル頻度に関する研究 Ver1.2(MH2021-180).pdf
Opt-out docs None
Approval docs MH2021-180_20220222
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RB Approval # HG2022-001
Title An observational study for "OTS-Assay", a rapid diagnostic system using digital PCR (dPCR) quantifying circulating tumor DNA (ctDNA) of cancer patients (OTS-Assay observational study, OTS-AO study)
First Approval May 7, 2022
Period May 11, 2022~May 11, 2027
Update Approval May 7, 2022
PI Satoshi Nishizuka, M.D., Ph.D.
Recruit Active
Protocol docs 研究計画書_ver1.1_05162022pdf
IC docs 患者説明書・同意書_ver1.2_05162022.pdf
Opt-out docs 情報公開文書_05162022.pdf
Approval docs HG2022-001_20220507.pdf
Status Active

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