臨床研究支援事業

成果一覧

CSPOR

乳癌

N-SAS BC 07 (RESPECT)

The Breast 66: 245-254, 2022

Adjuvant trastuzumab without chemotherapy for treating early HER2-positive breast cancer in older patients: a propensity score-adjusted analysis of a prospective cohort study.(澤木 正孝:愛知県がんセンター)

Clin Drug Investig 42: 253-262, 2022

Cost-effectiveness of trastuzumab with or without chemotherapy as adjuvant therapy in HER2-positive elderly breast cancer patients: a randomized, open-label clinical trial, the RESPECT trial.(宅本 悠希:国立保健医療科学院)

Breast Cancer Res Treat 188: 675-683, 2021

Impact of chemotherapy on cognitive functioning in older patients with HER2-positive breast cancer: a sub-study in the RESPECT trial.(萩原 康博:東京大学大学院)

J Clin Oncol 39: 2452-2462, 2021

Health-Related Quality of Life With Trastuzumab Monotherapy Versus Trastuzumab Plus Standard Chemotherapy as Adjuvant Therapy in Older Patients With HER2-Positive Breast Cancer.(平 成人:岡山大学病院)

J Clin Oncol 38: 3743-3752, 2020

Randomized Controlled Trial of Trastuzumab With or Without Chemotherapy for HER2-positive Early Breast Cancer in Older Patients.(澤木 正孝:愛知県がんセンター)

第42回サンアントニオ乳がんシンポジウム/2019年12月

A cohort study to evaluate the efficacy and safety of postoperative adjuvant therapy in HER2-positive elderly breast cancer patients (RESPECT-cohort study).(相良病院 馬場 信一)

第41回サンアントニオ乳がんシンポジウム/2018年12月

Analysis of cognitive function in elderly patients with HER2-positive breast cancer receiving trastuzumab monotherapy or trastuzumab plus chemotherapy as postoperative adjuvant therapy: A cognitive function sub-study of a randomized, open-label, phase 3 clinical trial (RESPECT trial).(北海道がんセンター 高橋 將人)

第41回サンアントニオ乳がんシンポジウム/2018年12月

Patient-reported outcomes with trastuzumab monotherapy versus trastuzumab plus standard chemotherapy as a postoperative adjuvant therapy in HER2-positive elderly breast cancer patients (RESPECT): A randomized, open-label, phase 3 clinical trial. (がん研有明病院 小林 心)

International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Asia Pacific/2018年9月

The EQ-5D index of elderly patients with HER20positive breast cancer: results from the randomized N-SAS BC 07 trial for adjuvant trastuzumab with and with our chemotherapy.(東京大学 萩原 康博)

2018 ASCO annual meeting/2018年6月

Evaluation of trastuzumab without chemotherapy as a postoperative adjuvant therapy in HER2 positive elderly breast cancer patients: Randomized controlled trial (RESPECT).(澤木 正孝 愛知県がんセンター)

第38回サンアントニオ乳がんシンポジウム/2015年12月

A randomized controlled trial of postoperative adjuvant therapy for elderly breast cancer patients: Comparison of health-related quality of life between clinical trial participants and decliners. (さいたま赤十字病院 斉藤 毅)

第38回サンアントニオ乳がんシンポジウム/2015年12月

A randomized clinical trial of postoperative adjuvant therapy for elderly breast cancer patients: Conditions of obtaining informed consent and reasons for declining participation. (相良病院 相良 安昭)


乳癌

N-SAS BC 06 (NEOS)

Spotlight Session (poster discussion), San Antonio Breast Cancer Symposium, Dec. 2021

H. Iwata, T. Toyama, N. Taira, et al. Primary analysis from NEOS trial: a randomized phase III study that assessed the long-term prognosis of estrogen receptor positive (ER+) primary breast cancer (PBC) pts who received neoadjuvant endocrine therapy (NET) with/without adjuvant chemotherapy (CT)

厳選口演 第27回日本乳癌学会総会:2019年7月

閉経後乳癌における術前内分泌療法の意義 ~ NEOS試験から得たエビデンス ( 増田慎三:国立病院機構大阪医療センター 乳腺外科)

Poster Session, San Antonio Breast Cancer Symposium, Dec. 2017

Hiroji Iwata, Norikazu Masuda, Yutaka Yamamoto, et al. T TransNEOS: Validation of the Oncotype DX Breast Recurrence Score® test on core needle biopsy samples from NEOS as predictor of clinical response to neoadjuvant endocrine therapy for postmenopausal ER+, HER2-negative breast cancer patients

Oral session, ESMO 2018 Congress, Oct. 2018

Hiroji Iwata (Aichi Cancer Center Hospital). Distant disease-free survival (DDFS) according to response category in neoadjuvant endocrine therapy (NET): 6-Year analysis in phase III NEOS trial

Poster session, San Antonio Breast Cancer Symposium, Dec. 2017

Hiroji Iwata, Yutaka Yamamoto, Takehiko Sakai, et al. NEOS: A randomized, open label, phase 3 trial of adjuvant chemotherapy for postmenopausal breast cancer patients who responded to neoadjuvant letrozole: First report of long-term outcome and prognostic value of response to neoadjuvant endocrine therapy

Poster Session, San Antonio Breast Cancer Symposium, Dec. 2015

Tomomi Fujisawa, Hiroji Iwata, Takehiko Sakai, et al. Endocrine-related symptoms during neoadjuvant endocrine therapy for breast cancer: Agreement between patient and physician reporting in a prospective clinical trial

Poster session, San Antonio Breast Cancer Symposium, Dec. 2014

Takehiro Sakai, Hiroji Iwata, Yoshie Hasegawa, et al. The first report of clinicopathological analysis at neoadjuvant treatment phase in NEOS, a randomized study of adjuvant endocrine therapy with or without chemotherapy for postmenopausal breast cancer patients who responded to neoadjuvant letrozole.

口演 第21回日本乳癌学会総会:2013年6月

術前ホルモン療法における超音波による治療効果評価(NEOSデータから得られたこと) (中島 一毅:川崎医科大学 総合外科学)

Poster session(TPS), ASCO Annual Meeting, Jun. 2013

Hiroji Iwata, Schoichiro Ohtani, Tomomi Fujisawa, et al. N-SAS BC06: A phase III study of adjuvant endocrine therapy with or without chemotherapy for postmenopausal breast cancer patients who responded to neoadjuvant letrozole (LET): the new primary endocrine-therapy origination study (NEOS).

Poster session, ASCO Annual Meeting, Jun. 2013

Shoichiro Ohtani, Naruto Taira, Kiyohiro Kihara, et al. Analysis of health-related quality of life during neoadjuvant endocrine therapy with letrozole in postmenopausal breast cancer patients: N-SAS BC06 trial

Poster session, San Antonio Breast Cancer Symposium, Dec. 2011

Iwata H, Yamaguchi T, Masuda N, et al. A randomized study of adjuvant endocrine therapy with or without chemotherapy for postmenopausal breast cancer patients who responded to neoadjuvant letrozole: An interim efficacy analysis of the new primary endocrine-therapy origination study (NEOS / N-SAS BC06)

Poster session, St. Gallen International Breast Cancer Conference, March 2009

H. Iwata, N. Masuda, T. Toyama, et al. A PHASE III STUDY OF ADJUVANT ENDOCRINE THERAPY WITH OR WITHOUT CHEMOTHERAPY FOR POSTMENOPAUSAL BREAST CANCER PATIENTS WHO RESPONDED TO NEOADJUVANT LETROZOLE: STUDY DESIGN OF THE NEW PRIMARY ENDOCRINE-THERAPY ORIGINATION STUDY[NEOS(N-SAS BC06)]


乳癌

N-SAS BC 05 (AERAS)

Oral session, San Antonio Breast Cancer Symposium, Dec. 2018

Shoichiro Ohtani (Hiroshima City Hiroshima Citizens Hospital) A prospective randomized multi-center open-label phase Ⅲ trial of extending aromatase-inhibitor adjuvant therapy to 10 years - results from 1697 postmenopausal women in the N-SAS BC 05 trial: Arimidex Extended adjuvant Randomized Study (AERAS)

Poster session, St. Gallen International Breast Cancer Conference, Mar. 2011

H. Yagata, T. Iwase, H. Ohtsu, et al. Baseline assessment of patient-reported outcomes (PROs) for breast cancer patients after 5-years of endocrine treatment in a randomized clinical trial: NSAS-BC 05

口演 日本癌治療学会:2010年10月

乳癌術後アナストロゾール服用5年終了患者に対するベースラインQOL調査(N-SAS BC 05) (聖路加国際病院 乳腺外科 矢形 寛)


乳癌

Oral Care-BC

ポスター発表 第27回日本乳癌学会学術総会:2019年7月

エベロリムス治療における予後予測因子の検討 ~Oral Care-BC登録症例での解析~ (渡邊健一:北海道がんセンター)

シンポジウム 第27回日本乳癌学会学術総会:2019年7月

がんに対する薬物療法における歯科介入効果のエビデンス(ランダム化第3相臨床試験Oral Care-BC) (太田嘉英:東海大学医学部付属病院)

Poster session, 26th ISOQOL Annual Conference, Oct. 2019

Mariko Naito, Naoki Niikura, Katsuhiko Nakatukasa, et al. Oral care to prevent oral mucositis and the health-related quality of life in estrogen receptor-positive metastatic breast cancer patients treated with everolimus (Oral Care-BC): a randomized controlled phase III trial

Poster Session, San Antonio Breast Cancer Symposium, Dec. 2018

Naoki Niikura, Katsuhiko Nakatukasa, Takeshi Amamiya, et al. Oral Care Evaluation to Prevent Oral Mucositis in Estrogen Receptor-Positive Metastatic Breast Cancer Patients Treated with Everolimus (Oral Care-BC): A Randomized Controlled Phase III Trial

Poster Session (Ongoing Clinical Trials), San Antonio Breast Cancer Symposium, Dec. 2015

Naoki Niikura, Yoshihide Ota, Naoki Hayashi, et al. Evaluation of the use of oral care to prevent oral mucositis in estrogen receptor positive metastatic breast cancer patients treated with everolimus: Phase III randomized control trial.

シンポジウム 第13回日本臨床腫瘍学会学術集会(2015年7月)

エストロゲンレセプター陽性再発乳癌を対象とした エべロリムス使用症例における口内炎予防のための 歯科介入無作為化第Ⅲ相試験 (新倉直樹:東海大学医学部 乳腺・内分泌外科)


乳癌

POTENT

POSTER 2022 San Antonio Breast Cancer Symposium

Adjuvant S-1 plus endocrine therapy for estrogen receptor-positive, HER2-negative, primary breast cancer: updated overall survival analysis from the POTENT trial (POTENT-FU) (高田 正泰:京都大学)

Lancet Oncol . 2021 Jan;22(1):74-84. doi: 10.1016/S1470-2045(20)30534-9

Adjuvant S-1 plus endocrine therapy for oestrogen receptor-positive, HER2-negative, primary breast cancer: a multicentre, open-label, randomised, controlled, phase 3 trial Masakazu Toi , Shigeru Imoto , Takanori Ishida , Yoshinori Ito , Hiroji Iwata , Norikazu Masuda , Hirofumi Mukai , Shigehira Saji , Akira Shimizu , Takafumi Ikeda , Hironori Haga , Toshiaki Saeki , Kenjiro Aogi , Tomoharu Sugie , Takayuki Ueno , Takayuki Kinoshita , Yuichiro Kai , Masahiro Kitada , Yasuyuki Sato , Kenjiro Jimbo , Nobuaki Sato , Hiroshi Ishiguro , Masahiro Takada , Yasuo Ohashi , Shinji Ohno

一般口演 第28回日本乳癌学会学術総会2020年7月

ホルモン受容体陽性乳癌の術後内分泌療法におけるS-1の併用効果(杉江 知治:関西医科大学)

General Session 2019 San Antonio Breast Cancer Symposium

Addition of S-1 to endocrine therapy in the post-operative adjuvant treatment of hormone receptor-positive and human epidermal growth factor receptor 2-negative primary breast cancer: A multicenter, open-label, phase 3 randomized trial (POTENT trial)(戸井 雅和:京都大学)


肺癌

LC07 (Reiwa)

第62回日本肺癌学会学術集会・2021年11月

EGFR遺伝子変異陽性進行非小細胞肺癌における初回オシメルチニブの効果・安全性に関する観察研究(Reiwa) (突田容子; 東北大学病院 呼吸器内科)

BMJ Open / Accepted 14 December 2021.

Efficacy and safety of first-line osimertinib treatment and post-progression patterns of care in patients with epidermal growth factor receptor activating mutation-positive advanced non-small-cell lung cancer (Reiwa study): design and rationale of a multicenter, real-world observational study (Kageaki Watanabe; Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Bunkyo, Tokyo 113-8677, Japan.)


肺癌

LC05 (JP-CLEAR)

Japanese Journal of Clinical Oncology, Volume 49, Issue 6, June 2019, Pages 554–558,

Plasma ctDNA monitoring during epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor treatment in patients with EGFR-mutant non-small cell lung cancer (JP-CLEAR trial) (臼井 一裕:NTT東日本関東病院)



肺癌

LC-02

ESMO Open Cancer Horizons. DOI: 10.1136/esmoopen-2017-000214 / Published 14 September 2017

Continuing EGFR-TKI beyond radiological progression in patients with advanced or recurrent, EGFR mutation-positive non-small-cell lung cancer: an observational study (後藤 悌:国立がん研究センター中央病院)


肺癌

LC-01

Anticancer Research March 2017 vol. 37 no. 3 1507-1513

Impact of Maintenance Therapy for Patients with Non-small Cell Lung Cancer in a Real-world Setting (葉 清隆:国立がん研究センター東病院)



胃癌

REVIVE Study (GC-01)

ESMO Open, Volume 8 , Issue 6 / Published online: 27 December 2023

Chemotherapy after nivolumab for advanced gastric cancer (REVIVE): a prospective observational study(成田 有季哉:愛知県がんセンター)

ESMO-GI/2022年6月

Impact of Salvage Chemotherapy after Nivolumab Therapy (NIVO):A Sub-Study of REVIVE(松岡 宏:藤田医科大学病院)

日本胃癌学会/2022年3月4日

Efficacy of Salvage Chemotherapy (CTx) by Response to Prior Nivolumab (NIVO): A Sub-Study of REVIVE(川上 武志:静岡県立静岡がんセンター)

日本臨床腫瘍学会/2022年2月17日

REVIVE study: An Observational Study in Chemotherapy ( CTx ) after Nivolumab (NIVO) for Advanced Gastric Cancer (AGC)(坂本 康寛:大崎市民病院)

ASCO-GI/2022年1月21日

REVIVE study: A Prospective Observational Study in Chemotherapy (CTx) after Nivolumab (NIVO) Therapy for Advanced Gastric Cancer (AGC)(松島 知広:埼玉県立がんセンター)

Future Oncology, Volume 17, Issue 8 / Published online: 21 September 2020

REVIVE study: a prospective observational study in chemotherapy after nivolumab therapy for advanced gastric cancer(成田 有季哉:愛知県がんセンター)

日本臨床腫瘍学会/2019年7月18日

Chemotherapy after progREssiVe dIsease of niVolumab (NIV) thErapy (REVIVE study)(成田 有季哉:愛知県がんセンター)

日本胃癌学会/2019年2月28日

Trial in Progress: Chemotherapy after progREssiVe dIsease of niVolumab thErapy (REVIVE study)(成田 有季哉:愛知県がんセンター)

ASCO-GI/2019年1月

REVIVE study: Prospective observational study of efficacy and safety in chemotherapy after progREssiVe dIsease of niVolumab (NIV) thErapy for metastatic gastric cancer (mGC) (成田 有季哉:愛知県がんセンター)


肝細胞癌

RACB

BMC Cancer / Published on 21 August 2023

Protocol of the RACB study: a multicenter, single-arm, prospective study to evaluate the efficacy of resection of initially unresectable hepatocellular carcinoma with atezolizumab combined with bevacizumab(奥野 将之:兵庫医科大学)


肝細胞癌

LENS-HCC

日本肝癌研究会/2022年5月13日

切除不能肝細胞癌に対するレンバチニブ投与によるコンバージョン⼿術 -多施設前向き研究LENS-HCC trial-  Multicenter, single-arm trial to evaluate the efficacy of lenvatinib to achieve conversion surgery for initially unresectable hepatocellular carcinoma: LENS-HCC trial(日髙 匡章:長崎大学)

ASCO-GI/2022年1月21日

Multicenter prospective study to evaluate the efficacy of lenvatinib to achieve conversion surgery for initially unresectable hepatocellular carcinoma: LENS-HCC trial(多田 正晴:兵庫医科大学病院)

日本癌治療学会/2019年10月25日

Multicenter, single-arm trial of lenvatinib followed by surgical resection for initially unresectable hepatocellular carcinoma: LENS-HCC trial(市田 晃彦:東京大学医学部附属病院)


肝細胞癌

SURF trial付随研究

ESMO / Poster session 13・2022年9月10日

Medical expenditures and treatment efficacy of patients who had initial hepatocellular carcinoma and underwent surgery or radiofrequency ablation: Accompanying research of the SURF trial(河口 義邦:東京大学)


前立腺癌

URO 01(PROSAS-Study)

第108回日本泌尿器科学会総会 / 2020年12月

低リスク前立腺癌患者を対象とした低用量クロルマジノンの監視療法継続率に対する効果を検討する多施設共同、プラセボ対照、無作為化二重盲検群間比較試験 (PROSAS試験 )(鳥本 一匡:奈良県立医科大学)


腎癌

J-ACTOR

第54回日本癌治療学会学術集会 / 2016年10月

根治切除不能または転移性の腎細胞癌患者に対するエベロリムス投与前後のQOL変化(杉山貴之:浜松医科大学泌尿器科学講座)

第104回日本泌尿器科学会総会 / 2016年4月23日

根治切除不能または転移性の腎細胞癌患者 に対する1st line TKI療法不応後の エベロリムスの有効性および安全性の検討 ― 多施設共同第Ⅱ相試験 ―(杉山貴之:浜松医科大学泌尿器科学講座)

ASCO-GU / 2014年1月30日~2月1日

Multi-center phase II clinical trial of everolimus in Japanese patients with unresectable or metastatic renal cell carcinoma (mRCC) after failure of treatment with 1st-line tyrosine kinase inhibitor (TKI) therapy(大園 誠一郎:浜松医科大学泌尿器科学講座)


CSP-A-TOP

J-05

JOINT-05

J Bone Miner Metab; 2023 Oct 28. doi: 10.1007/s00774-023-01466-3

Reliability of early stage symptoms/clinical findings of osteonecrosis of the jaw: Japanese Osteoporosis Intervention Trial-05 (JOINT-05), Akira Taguchi, Shiro Tanaka, Tatsuro Ozaki, Koshiro Arai, Satoshi Mori, Hiroaki Ohta, Hiroshi Hagino, Sakae Tanaka, Masataka Shiraki, Toshitaka Nakamura, Satoshi Soen; Adequate Treatment of Osteoporosis (A-TOP) Research Group

Osteoporosis International; https://doi.org/10.1007/s00198-022-06570-0

Sequential therapy with once‑weekly teriparatide injection followed by alendronate versus monotherapy with alendronate alone in patients at high risk of osteoporotic fracture: final results of the Japanese Osteoporosis Intervention Trial‑05. Mori, S., Hagino, H., Sugimoto, T., Tanaka, S., Mitomo, Y., Takahashi, K.

Osteoporosis International; https://doi.org/10.1007/s00198-021-05996-2

A randomized, controlled trial of once-weekly teriparatide injection versus alendronate in patients at high risk of osteoporotic fracture: primary results of the Japanese Osteoporosis Intervention Trial-05. Hagino, H., Sugimoto, T., Tanaka, S., Sone, T., Nakamura, T., Soen, S., Mori, S.

J Bone Miner Metab ; 2020, 38, 412–417.

Design of a randomized trial of teriparatide followed by alendronate:Japanese Osteoporosis Intervention Trial‑05 (JOINT‑05). Tanaka, S., Mori, S., Hagino, H., Sugimoto, T.


J-04

JOINT-04

Arch Osteoporos. 2021 Dec 27;17(1):7. doi: 10.1007/s11657-021-01054-w.

Influence of symptomatic periodontal disease on changes in skeletal bone density during medication therapy for osteoporosis in postmenopausal women: the Japanese Osteoporosis Intervention Trial (JOINT)-04 and JOINT-05. Taguchi, A., Uemura, Y., Tanaka, S., Ohta, H., Mori, S., Hagino, H., Shiraki, M., Nakamura, T., Soen, S., for the Adequate Treatment of Osteoporosis (A-TOP) research. group.

J Bone Miner Metab; 2021, 39:668-677. doi: 10.1007/s00774-021-01208-3.

Risk factors for incident vertebral fractures in osteoporosis pharmacotherapy: a 2-year, prospective, observational study. Hagino, H., Uemura, Y., Mori, S., Sone, T., Ohta, H., Nakamura, T.

Curr Med Res Opin; 2020,36(11),1847-1859. doi: 10.1080/03007995.2020.1816537. Epub 2020 Sep 14

Randomized head-to-head comparison of minodronic acid and raloxifene for fracture incidence in postmenopausal Japanese women: the Japanese Osteoporosis Intervention Trial (JOINT)-04.  Uemura, Y., Sone, T., Tanaka, S., Miyazaki, T., Tsukiyama, M., Taguchi, A., Soen, S., Mori, S., Hagino, H., Sugimoto, T., Fukunaga, M., Ohta, H., Nakamura, T., Orimo, H., Shiraki, M., for the Adequate Treatment of Osteoporosis (A-TOP) Research Group.

J Bone Miner Metab ; 2019,37, 886–892.

Incidence of osteonecrosis of the jaw in Japanese osteoporosis patients taking minodronic acid. Taguchi, A., Uemura, Y., Imai, T., Tanaka, S., Ohta, H., Nakamura, T., Orimo, H., Sugimoto, T., Soen, S., Shiraki, M., for the Adequate Treatment of Osteoporosis(A-TOP) research group.

J Bone Miner Metab; 2019,37(3),491-495. doi: 10.1007/s00774-018-0942-z. Epub 2018 Jul 17.

Study design of multi-center, open-label randomized controlled, head-to-headtrial comparing minodronic acid and raloxifene: Japanese Osteoporosis Intervention Trial (JOINT)-04. Uemura, Y., Tanaka, S., Miyazaki, T., Tsukiyama, M., Sone, T., Taguchi, A., Soen, S., Mori, S., Hagino, H., Sugimoto, T., Fukunaga, M., Ohta, H., Nakamura, T., Orimo, H., Shiraki, M., for the Adequate Treatment of Osteoporosis (A-TOP) research group.


J-03

JOINT-03

Osteoporos Int; 2017,28(6),1893-1901.DOI 10,1007/S 00198-017-3966-7

Health state utility values and patient-reported outcomes before and after vertebral and non-vertebral fractures in an osteoporosis clinical trial. Imai, T., Tanaka, S., Kawakami, K., Miyazaki, T., Hagino, H., Shiraki, M., for the A-TOP(Adequate Treatment of Osteoporosis) Research Group.

J Bone Miner Metab ; 2017,35(4);385-395.DOI 10.1007/s00774-016-0768-5

Comparison of concurrent treatment with vitamin K2 and risedronate compared with treatment with risedronate alone in patients with osteoporosis: Japanese Osteoporosis Intervention Trial-03. Tanaka, S., Miyazaki, T., Uemura, Y., Miyakawa, N., Gorai, I., Nakamura, T., Fukunaga, M., Ohashi, Y., Ohta, H., Mori, S., Hagino, H., Hosoi, T., Sugimoto, T., Itoi, E., Orimo, H., Shiraki, M.

J Bone Miner Metab;32(3); 298-304, 2014

Design of a randomized clinical trial of concurrent treatment with vitamin K2 and risedronate compared to risedronate alone in osteoporotic patients: Japanese Osteoporosis Intervention Trial-03 (JOINT-03). Tanaka, S., Miyazaki, T., Uemura, Y., Kuroda, T., Miyakawa, N., Nakamura, T., Fukunaga, M., Ohashi, Y., Ohta, H., Mori, S., Hagino, H., Hosoi, T., Sugimoto, T., Itoi, E., Orimo, H., Shiraki, M.


J-02

JOINT-02

J Orthop Sci. ; 2020,S0949-2658(20)30332-8.

Impact of bone mineral density in reducing fracture risk in patients receiving alendronate plus alfacalcidol therapy. Itoi, E., Uemura, Y., Ohta, H., Nakamura, T., Fukunaga, M., Orimo, H., Shiraki, M.

Clin Therap; 2014,36(2),225-235.

Serum 25 hydroxyvitamin D level as an independent determinant of quality of life in osteoporosis with high risk for fracture. Ohta, H., Uemura, Y., Nakamura, T., Fukunaga, M., Ohashi, Z., Hosoi, T., Mori, S., Sugimoto, T., Itoi, E., Orimo, H., Shiraki, M., Adequate Treatment of Osteoporosis.(A-TOP)research group.

J Bone Miner Metab; 2015,33(6):,642-650.

Comparison of expert and nonexpert physicians in the assessment of vertebral fractures using the semiquantitative method in Japan. Uemura, Y., Miyakawa, N., Orimo, H., Shiraki, M., Nakamura, T., Mori, S.

Curr Med Res Opin; 2011,27(6),1273-84.

Effects of alendronate plus alfacalcidol in osteoporosis patients with a high risk of fracture: the Japanese Osteoporosis Intervention Trial (JOINT)- 02. Orimo, H., Nakamura, T., Fukunaga, M., Ohta, H., Hosoi, T., Uemura, Y., Kuroda, T., Miyakawa, N., Ohashi, Y., Shiraki, M., A-TOP (Adequate Treatment of Osteoporosis)research group.

J Bone Miner Metab; 2011,29(1),37-43.

Design of a pragmatic approach to evaluate the effectiveness of concurrent treatment for the prevention of osteoporotic fractures: rationale, aims and organization of a Japanese Osteoporosis Intervention Trial(JOINT) initiated by the Research Group of Adequate Treatment of Osteoporosis (A-TOP). Shiraki, M., Kuroda, T., Hosoi, T., Ohashi, Y., Ohta, H., Fukunaga, M., Nakamura, T., Orimo, H.,et al.


A-01

JOB

Journal of Epidemiology;https://doi.org/10.2188/jea.JE20220099

Impact of Osteonecrosis of the Jaw on Osteoporosis Treatment in Japan: Results of a Questionnaire-Based Survey by the Adequate Treatment of Osteoporosis (A-TOP) Research Group. Imai, T., Hosoi, T., Hagino, H., Yamamoto, T., Kuroda, T., Watanabe, H., Tanaka, S.

Jpn J Pharmacoepidemiol;21(1);13-19,2016,DOI.org/10.3820/jjpe.21.13

Validation Study of Claims-based Definitions of Suspected Atypical Femoral Fractures Using Clinical Information. Tanaka, S., Hagino, H., Ishizuka, A., Miyazaki, T., Yamamoto, T., Hosoi, T.


CSP-LD






LD-09

REAL-CAD

American Heart Association(AHA)_ Late breaking/ 2017年11月13日

Does High-Intensity Pitavastatin Therapy Further Improve Clinical Outcomes?
Takeshi Kimura, Teruo Inoue, Isao Taguchi, Hiroshi Iwata, Satoshi Iimuro, Takafumi Hiro, Yoshihisa Nakagawa, Yukio Ozaki, Yasuo Ohashi, Hiroyuki Daida, Hiroaki Shimokawa, Ryozo Nagai, on behalf of the REAL-CAD Study Investigators


LD-08

EWTOPIA75

American Heart Association(AHA)_Late breaking/2018年11月10日

Ezetimibe in Prevention of Cerebro- and Cardiovascular Events in Middle- to High-Risk, Elderly (75 Years Old or Over) Patients With Elevated LDL-Cholesterol.
 Yasuyoshi Ouchi , Hidenori Arai, Jun Sasaki, Koutaro Yokote, Masanari Kuwabara, Kazumasa Harada, Takumi Imai, Shiro Tanaka, Yasuo Ohashi, Hideki Ito on behalf of the EWTOPIA investigators





疫学調査

JEDAS Study

米国糖尿病学会 ニューオリンズ・2009年6月

JEDAS研究第2報 / 田中俊一 / 医療法人金沢内科クリニック


CSP-HOR

乳癌

HOR 22

ISPOR Annual European Congress(2015年)

Effects of adverse events on quality of life scores in a randomized clinical trial of adjuvant chemotherapy for breast cancer patients: N-SAS BC 02 / 抗癌薬治療中乳がん患者におけるの副作用のQOLへの影響(國澤進:京都大学)


乳癌

HOR 20

乳癌の臨床 29,2;203-209,2014

乳癌化学療法に伴う脱毛患者へのサポートに関するアンケート調査(矢形寛:聖路加国際病院)

Supportive Care in Cancer(MASCC)(2015年)

Patients’ recognition of long-term chemotherapy-related changes in their hair and differences among drugs / 乳癌化学療法経験者に対する脱毛調査(吉田悠子:順天堂大学)

サンアントニオ乳癌シンポジウム(2014年)

National survey of long-term recovery from chemotherapy-induced hair loss in breast cancer patients / 乳癌化療経験者に対する脱毛調査(矢形寛:聖路加国際病院)

サンアントニオ乳癌シンポジウム(2014年)

National survey of chemotherapy-induced appearance issues in breast cancer patients / 乳癌化療経験者に対する脱毛調査(渡辺隆紀:仙台医療センター)


大腸癌

HOR 19

国際薬剤経済学/アウトカム研究学会(ISPOR)ヨーロッパ会議(2010年)

Cost-effectiveness of adjuvant FOLFOX therapy for stage III colon cancer in Japan / 大腸癌術後補助療法におけるFOLFOX療法の医療経済学的評価(福田敬:東京大学)



大腸癌

HOR 15

Pharmacoeconomics 27,7;597-608,2009

大腸癌術後補助療法におけるカペシタビンの薬剤経済学的分析(白岩健:東京大学)


乳癌

HOR 14

国際薬剤経済学/アウトカム研究学会(ISPOR)ヨーロッパ会議(2007年)

Basic attitude to use of generic anti-cancer drugs for breast cancer treatment in Japan / 乳がん臨床医を対象とした後発医薬品使用に関する調査(斎藤信也:高知女子大学)


肺癌

HOR 13

Journal of Thoracic Oncology 9;231-238,2014

肺癌患者における骨転移・骨関連事象に関する調査(片上信之:先端医療センター)

欧州癌治療学会議(ESMO)(2013年)

A prospective analysis of the association between skeletal-related events and quality of life in patients with advanced lung cancer (CSP-HOR13) / 肺癌患者における骨関連事象とQOLに関する解析(横山太郎:横浜市立市民病院)

欧州癌治療学会議(ESMO)(2011年)

Incidence of bone metastases and skeletal-related events in patients with advanced lung cancer: results of a multicenter, prospective, cohort study (CSP-HOR13) / 肺癌患者における骨転移、骨関連事象に関する調査(関順彦:帝京大学)

米国臨床腫瘍学会 (ASCO)(2011年)

Prospective study on incidence of bone metastasis (BM) and skeletal related events (SREs) in patients (pts) with stage IIIB and IV lung cancer (CSP-HOR13) / 肺癌患者における骨転移・骨関連事象に関する調査(片上信之:先端医療センター)


前立腺肥大

HOR 12

Advance in Urology 2013

酢酸クロルマジノンの前立腺癌患者の排尿機能に与える影響(藤本清秀:奈良県立医科大学)

泌尿器科紀要 57;177-183,2011

酢酸クロルマジノン投与による前立腺肥大症患者の血清PSA値およびテストステロン値の変動(藤本清秀:奈良県立医科大学)


乳癌

HOR 10

Palliative Care Research 9;132-139,2014

乳腺外来におけるうつ状態診療の実態調査(佐藤泉美:東京大学)


乳癌

HOR 09

Breast Cancer Research and Treatment 109,3;559-566,2008

乳癌術後補助療法におけるトラスツズマブの薬剤経済学的分析(白岩健:東京大学)


アトピー

HOR 08

British Journal of Dermatology 161,3;617-625,2009

アトピー性皮膚炎患児の養育者に特異的なQOL尺度の開発(Kondo-Endo K:京都大学)


多癌腫

HOR 04-1

Tokai J Exp Clin Med 38,1;7-11,2013

がん患者の貧血とQOL (稙田いずみ:東海大学)

Supportive Care in Cancer 15;1-6,2007

がん患者の貧血とQOL(栗田まや:四国がんセンター)

Society of Clinical Research Associates(SoCRA)(2005年)

Another expected effect of CRCs-initiated cooperative study / がん患者の貧血とQOL(後澤乃扶子:国立がんセンター中央病院)


乳癌

HOR 03

広島大学保健学ジャーナル 3,1;46-54,2003

医療施設内における乳がん患者会の存在と役割(溝口全子:広島大学)


乳癌

HOR 02

Supportive Care in Cancer 17;1071-1080,2009

神経毒性に関するQOL調査(黒井克昌:東京都立駒込病院)

米国臨床腫瘍学会(ASCO)(2007年)

Prospective assessment of chemotherapy-induced neurotoxicity in breast CSPOR (Comprehensive Support Project for Oncological Research) cancer (HOR 02) and questionnaire survey of physicians’ perspectives / 神経毒性に関するQOL調査(黒井克昌:東京都立駒込病院)


乳癌

SELECT BC

サンアントニオ乳癌シンポジウム(2014年)

Randomized phase III trial of taxanes versus S-1 as first-line chemotherapy for metastatic breast cancer (SELECT BC) / HRQOL評価(渡辺隆紀:仙台医療センター)


乳癌

N-SAS BC 06

Breast Cancer Research and Treatment 145;155-164, 2014

術前内分泌療法のQOL評価(平成人:岡山大学病院)

米国臨床腫瘍学会(2013年)

Analysis of health-related quality of life during neoadjuvant endocrine therapy with letrozole in postmenopausal breast cancer patients: N-SAS BC06 trial / 術前内分泌療法のQOL評価(大谷彰一郎:広島市立広島市民病院)


乳癌

N-SAS BC 05

Suppohive Care in Cancer 2015

ベースラインのQOLの調査(矢形寛:埼玉医科大学)

国際初期乳癌治療会議(2013年)

Comparison patient-reported outcomes (PROs) between the continuation and stop groups after 5 years of anastrozole: NSAS-BC 05 / QOL(矢形寛:聖路加国際病院)

国際初期乳癌治療会議(2013年)

Comparison of bone health in continuation and stop groups after 5 years of anastrozole: NSAS-BC 05 / 骨密度(武井寛幸:埼玉県立がんセンター)

国際初期乳癌治療会議(2013年)

Joint symptoms in continuation and stop groups after 5 years of anastrozole : NSAS-BC 05 / 関節症状(檜垣健二:広島市立広島市民病院)

国際初期乳癌治療会議(2011年)

Baseline assessment of patient-reported outcomes (PROs) for breast cancer patients after 5-years of endocrine treatment in a randomized clinical trial: NSAS-BC 05 / ベースラインQOLの調査(矢形寛:聖路加国際病院) 


乳癌

N-SAS BC 04

Breast Cancer Research and Treatment 133;227-236, 2012

HRQOLの評価(武井寛幸:埼玉県立がんセンター)

サンアントニオ乳癌シンポジウム(2009年)

Health-related quality of life (HRQOL) and psychological distress in Japanese postmenopausal women with breast cancer treated with tamoxifen, exemestane or anastrozole for adjuvant endocrine therapy: a final analysis for HQOL in National Surgical Adjuvant Study of Breast Cancer (N-SAS BC) 04 / HRQOLの評価(武井寛幸:埼玉県立がんセンター)

サンアントニオ乳癌シンポジウム(2007年)

Health-related quality of life and psychological distress in Japanese patients with breast cancer treated with tamoxifen, exemestane or anastrozole for adjuvant therapy: A phase III randomized study of National Surgical Adjuvant Study of Breast Cancer (N-SAS BC) 04 / HRQOLの評価(竹原めぐみ:自治医科大学)

サンアントニオ乳癌シンポジウム(2006年)

Health-related quality of life and psychological distress of breast cancer patients after surgery during phase III randomized trial comparing tamoxifen, exemestane, and anastrozole: N-SAS BC 04 / HRQOLの評価(武井寛幸:埼玉県立がんセンター)


乳癌

N-SAS BC 03

Breast Cancer Research and Treatment 127,1; 143-152, 2011

HRQOLの評価(大住省三:四国がんセンター)

サンアントニオ乳癌シンポジウム(2008年)

Health-related quality-of-life and psychological distress of postmenopausal breast cancer patients after surgery during the randomized trial, N-SAS BC 03, comparing further tamoxifen with switching to anastrozole after adjuvant tamoxifen for 1 to 4 years: the final results / HRQOLの評価(大住省三:四国がんセンター)

サンアントニオ乳癌シンポジウム(2005年)

Health-related quality of life and psychological distress of breast cancer patients after surgery during phase Ⅲ randomized trial comparing further tamoxifen with switching to anastrozole after adjuvant tamoxifen for 1 to 4 years: N-SAS BC03 / HRQOLの評価(大住省三:四国がんセンター)


乳癌

N-SAS BC 02

Supportive Care in Cancer 20;3355-3364,2012

末梢神経障害とQOLに及ぼす影響(下妻晃二郎:立命館大学)

Oncology 82;131-138,2012

浮腫(大住省三:四国がんセンター)

Value in Health 14,5;746-51,2011

HRQOLにおけるEQ-5Dの成績(白岩健:立命館大学)

Supportive Care in Cancer 17;1483-1491,2009

神経毒性-評価尺度の妥当性と結果(下妻晃二郎:立命館大学)

Japanese Journal of Clinical Oncology 38,11;748-754,2008

神経毒性-評価尺度の妥当性と結果(黒井克昌:東京都立駒込病院)

国際薬剤経済学/アウトカム研究学会(ISPOR)ヨーロッパ会議(2010年)

Comparison of EQ-5D score between treatment with 4 cycles of anthracycline followed by 4 cycles of taxane and 8 cycles of taxane for node positive breast cancer patients after surgery: N-SAS BC 02 trial / HRQOLにおけるEQ-5Dの成績(下妻晃二郎:立命館大学)

サンアントニオ乳癌シンポジウム(2009年)

Objective and subjective assessment of edema during adjuvant chemotherapy using taxane-containing regiments in a randomized controlled trial; National Surgical Adjuvant Study of Breast Cancer (N-SAS BC) 02 / 浮腫(大住省三:四国がんセンター)

米国臨床腫瘍学会(ASCO)(2006年)

Assessment and quantification of taxane-induced neurotoxicity in a phase Ⅲ randomized trial of patients with breast cancer (AC followed by PAC/DOC vs. PAC/DOC alone): N-SAS BC02 / 神経毒性-評価尺度の妥当性と結果(下妻晃二郎:流通科学大学)

サンアントニオ乳癌シンポジウム(2004年)

Validation of the patient neurotoxicity questionnaire (PNQ) during taxane chemotherapy in a phase III randomized trial in patients with breast cancer: N-SAS BC 02 / 神経毒性-評価尺度の妥当性(下妻晃二郎:流通科学大学)


CSP-CCR

C-10

子宮がん予防意識調査

第66回日本産科婦人科学会学術講演会/2014

子宮頸がん予防に対する女性医療従事者の意識調査・入江琢也


C-09

J-HERS4

日本性感染症学会誌 2013; 24(1): 103-9/2013

尖圭コンジローマ患者のQOL調査:多施設共同研究 (J-HERS Study)・入江, et al.

第65回 日本産科婦人科学会学術講演会/2013

尖圭コンジローマに罹患した日本人女性のQuolity of Life (QOL) 調査: 多施設共同研究 (J-HERS Study)・伊藤富士子

第25回 日本性感染症学会学術大会/2012

尖圭コンジローマ患者のQOL調査・入江琢也

28th International Papillomavirus Conference (IPV)/2012

Multi-Center Study (J-HERS) for Quality of Life of Women with Genital Warts in Japan -Interim Report-・F Ito


C-08

J-HERS3

第52回 日本臨床細胞学会 秋季大会/2013

日本における高リスク型HPVを再考する・伊藤富士子

第54回 日本臨床細胞学会総会 春季大会/2013

子宮頚部細胞診とHPV感染および型別診断の大規模研究:J-HERS多施設共同研究・前濱俊之

第54回 日本臨床細胞学会総会 春季大会/2013

子宮頚部液状細胞診とHPV-DNA検査併用の意義:J-HERS大規模調査・笹川寿之

第65回 日本産科婦人科学会学術講演会/2013

日本人女性の子宮頚部に感染するHPV型と細胞診談の大規模研究:多施設共同研究 (J-HERS Study)・前濱俊之

第25回 日本性感染症学会学術大会/2012

HPV DNA型調査・前濱俊之

28th International Papillomavirus Conference (IPV)/2012

A multii-center study (J-HERS) for prevalent HPV genotypes and abnormal cytology in young Japanese women・T Sasagawa


C-06

J-HERS1

27th International Papillomavirus Conference (IPV)/2011

Estimation of the incidence of genital wart, cervical intraepithelial neoplasia and cervical cancer in Japan (J-HERS)・T Sasagawa


C-05

COPD研究

日本呼吸器学会/2014

呼吸器疾患未治療の日本人COPD患者に対するガイドライン薬物治療効果の検討・瀬戸口靖弘(東京医科大学病院)


その他