| 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 |
| Status | Active |
| RB Approval # | H28-85 |
|---|---|
| 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 31, 2026 |
| Update Approval | Sep 14, 2022 |
| PI | Mizunori Yaegashi, M.D., Ph.D. |
|---|---|
| Recruit | Active |
| Protocol docs | 研究計画書_ver1.6_申請用.pdf |
| IC docs | 患者同意書_v1.6.pdf |
| Opt-out docs | H28-85_HGH28-15_情報公開文書_03272020.pdf |
| Approval docs | H28-85_20200417.pdf |
| Status | Active |
| 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 31, 2026 |
| Update Approval | Sep 14, 2022 |
| PI | Mizunori Yaegashi, M.D., Ph.D. |
|---|---|
| Recruit | Active |
| Protocol docs | 研究計画書_ver1.6_申請用.pdf |
| IC docs | 患者同意書_v1.6.pdf |
| Opt-out docs | H28-85_HGH28-15_情報公開文書_03272020 |
| Approval docs | HGH28-85_20201207.pdf |
| Status | Active |
| 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 15, 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 |
| RB Approval # | HGH28-13 |
|---|---|
| Title | Information-based personalized medicine using artificial intelligence (tent.) |
| First Approval | Sep 21, 2016 |
| Period | Sep 21, 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 |
| Status | Active |
| RB Approval # | HGH28-14 |
|---|---|
| Title | Genetic analysis of rare, refractory, and pediatric tumors for personalized medicine (tent.) |
| First Approval | Sep 21, 2016 |
| Period | Sep 21, 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 |
| Status | Active |
| 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 |
| Status | Active |
| 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 |
| Status | Active |
| 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, 2025 |
| Update Approval | May 15, 2024 |
| PI | Satoshi Nishizuka, M.D., Ph.D. |
|---|---|
| Recruit | None |
| Protocol docs | HG2019-003_研究計画書_ver3.72_03282024.pdf |
| IC docs | HG2019-003_患者説明書・同意書_ver3.72_03282024.pdf |
| Opt-out docs | HG2019-003情報公開文書_03282024.pdf |
| Approval docs | HG2019-003審査結果通知書.pdf |
| Status | Active |
| 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 |
| Status | Active |
| 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 | Jun 2, 2020〜Mar 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 |
| Status | Active |
| 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 | Sep 7, 2020〜Mar 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 |
| Status | Active |
| 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 |
| Status | Active |
| 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, 2025 |
| Update Approval | Aug 8, 2024 |
| PI | Satoshi S. Nishizuka, M.D., Ph.D. |
|---|---|
| Recruit | Active |
| Protocol docs | Protocol_OTS_EN2_240709.pdf |
| IC docs | 説明文書_OTS_EN2_240115.pdf |
| Opt-out docs | 情報公開文書_231220.pdf・情報公開文書(共同研究者用)_240704.pdf |
| Approval docs | HG2020-027審査結果通知書.pdf |
| Status | Active |
| 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 |
| 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～Mar 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 |
| Status | Active |
| 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 |
| Status | Active |
| 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 | Jan 4, 2022～Jan 31, 2027 |
| Update Approval | Sep 14, 2022 |
| PI | Satoshi Nishizuka, M.D., Ph.D. |
|---|---|
| Recruit | Active |
| Protocol docs | CHANGE_ES01_研究計画書Ver1.2.pdf |
| IC docs | CHANGE_ES01_患者説明書_Ver1.2.pdf |
| Opt-out docs | None |
| Approval docs | MH2021-139_20220914.pdf |
| Status | Active |
| 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 4, 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 |
| Status | Active |
| 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 14, 2022～Jul 31, 2026 |
| Update Approval | Mar 29, 2024 |
| PI | Akiko Yashima-Abo, M.D., Ph.D. |
|---|---|
| Recruit | Active |
| Protocol docs | ACTIVELONG_ver1.51.pdf |
| IC docs | ACTIVE説明文書ver1.51.pdf |
| Opt-out docs | None |
| Approval docs | MH2021-180審査結果通知書.pdf |
| Status | Active |
| 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 7, 2022～May 11, 2027 |
| Update Approval | Sep 12, 2024 |
| PI | Satoshi Nishizuka, M.D., Ph.D. |
|---|---|
| Recruit | Active |
| Protocol docs | HG2022-001研究計画書同意書ver1.52_202409.pdf |
| IC docs | HG2022-001説明書同意書ver1.52_202409.pdf |
| Opt-out docs | HG2022-001オプトアウト202409.pdf |
| Approval docs | HG2022-001審査結果通知書_20240912.pdf |
| Status | Active |
| RB Approval # | MH2022-048 |
|---|---|
| Title | Verification of DNA quality by long-term storage of FFPE blocks in surgical cases |
| First Approval | Aug 19, 2022 |
| Period | Aug 19, 2022～Dec 31, 2025 |
| Update Approval | Jul 26, 2023 |
| PI | Akiko Yashima-Abo, M.D., Ph.D. |
|---|---|
| Recruit | Active |
| Protocol docs | 手術例FFPEブロックの長期間保存によるDNAの品質検証（MH2022-048）第1.3版.pdf |
| IC docs | 手術例FFPEブロックの長期間保存によるDNAの品質検証（MH2022-048）第1.3版.pdf |
| Opt-out docs | 手術例FFPEオプトアウト第1.2版 |
| Approval docs | MH2022-048_20230726.pdf |
| Status | Active |
| RB Approval # | MH2023-107 |
|---|---|
| Title | Descriptive statistical analysis for clinical validity and utility evaluation of cancer genome profiling test in Iwate Medical University Hospital |
| First Approval | Feb 26, 2024 |
| Period | Feb 26, 2024～Feb 26, 2029 |
| Update Approval | Sep 12, 2024 |
| PI | Hiroaki Itamochi, M.D., Ph.D. |
|---|---|
| Recruit | Active |
| Protocol docs | MH2023-107研究計画書ver2.3 20240719.pdf |
| IC docs | MH2023-107研究計画書ver2.3 20240719.pdf |
| Opt-out docs | MH2023-107オプトアウト202407.pdf |
| Approval docs | MH2023-107審査結果通知書_20240912,pdf |
| Status | Active |
| RB Approval # | MH2023-118 |
|---|---|
| Title | Stratification of cases suitable for conversion surgery and evaluation of treatment outcomes for locally advanced unresectable pancreatic cancer using super sensitive tumor-informed ctDNA monitoring |
| First Approval | Apr 30, 2024 |
| Period | Apr 30, 2024～Dec 31, 2028 |
| Update Approval | Apr 30, 2024 |
| PI | Satoshi Nishizuka, M.D., Ph.D., |
|---|---|
| Recruit | Active |
| Protocol docs | 研究計画書_ver.1.2.pdf |
| IC docs | 説明文書_最終提出版.pdf |
| Opt-out docs | None |
| Approval docs | MH2023-118審査結果通知書.pdf |
| Status | Active |
| RB Approval # | MH2023-130 |
|---|---|
| Title | A cohort study on potential economic impact of 'OTS-assay' approached from medical records |
| First Approval | May 21, 2024 |
| Period | May 21, 2024～Mar 31, 2027 |
| Update Approval | May 21, 2024 |
| PI | Satoshi Nishizuka, M.D., Ph.D., |
|---|---|
| Recruit | None |
| Protocol docs | MH2023-130研究計画書_最終版.pdf |
| IC docs | None |
| Opt-out docs | MH2023-130オプトアウト文書_最終版.pdf |
| Approval docs | MH2023-130オプトアウト文書_最終版.pdf |
| Status |
| RB Approval # | MH2024-049 |
|---|---|
| Title | Prognostic evaluation of malignant lymphoma related to bone marrow minimal residual disease based on an originally developed relational database (MLDB study) |
| First Approval | Sep 24, 2024 |
| Period | Sep 24, 2024～Jul 31, 2028 |
| Update Approval | Sep 24, 2024 |
| PI | Akiko Yashima-Abo, M.D., Ph.D. |
|---|---|
| Recruit | Active |
| Protocol docs | 研究計画書_MLDB_Ver.1.31.pdf |
| IC docs | None |
| Opt-out docs | 情報公開文書_MLDB_Ver.1.2.pdf |
| Approval docs | MH2024-049審査結果通知書_20240917.pdf |
| Status | Active |