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利用者名:
UMIN ID:

試験進捗状況 限定募集中/Enrolling by invitation
UMIN試験ID UMIN000019417
受付番号 R000022378
科学的試験名
一般公開日(本登録希望日) 2015/10/20
最終更新日 2015/10/21

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Strain sUrveillance during Chemotherapy for improving Cardiovascular OUtcomes

一般向け試験名略称/Acronym
Strain sUrveillance during Chemotherapy for improving Cardiovascular OUtcomes (SUCCOUR Study)
科学的試験名/Scientific Title
Strain sUrveillance during Chemotherapy for improving Cardiovascular OUtcomes

科学的試験名略称/Scientific Title:Acronym
Strain sUrveillance during Chemotherapy for improving Cardiovascular OUtcomes (SUCCOUR Study)
試験実施地域/Region
日本/Japan アジア(日本以外)/Asia(except Japan)
北米/North America オセアニア/Australia
欧州/Europe

対象疾患/Condition
対象疾患名/Condition
Cancer therapeutics-related cardiac dysfunction
疾患区分1/Classification by specialty
循環器内科学/Cardiology
疾患区分2/Classification by malignancy 悪性腫瘍/Malignancy
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
The primary objective of this study is to show that information from strain imaging leads to the use of adjunctive therapy that will limit the development of reduced ejection fraction.
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes
The primary study end-point is change in 3D ejection fraction from baseline to up to three years, as determined by a blinded core laboratory and analyzed on an intention-to-treat basis according to random study group allocation.
副次アウトカム評価項目/Key secondary outcomes


基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 実薬・標準治療対照/Active
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 診断/Diagnosis
介入の種類/Type of intervention
その他/Other
介入1/Interventions/Control_1
Patients coming to the echo lab for echo surveillance of LV function will be randomized to provision of global strain (GLS) and ejection fraction (EF) or receive standard EF alone.
In the conventional imaging arm, if there is a symptomatic drop of more than 5% of ejection fraction, or a 10% asymptomatic drop of ejection fraction to EF <55%, the patient will be referred for initiation and titration of heart failure therapy (beta blockers and ACE inhibitors).
介入2/Interventions/Control_2
In the advanced cardiac imaging arm, if there is a reduction of global longitudinal strain by >12% in any of the follow-up echocardiograms (3,6,9,12), as compared to baseline, the patient will be referred for initiation and titration of heart failure therapy (beta blockers and ACE inhibitors).
the process of randomization will involve imaging strategy rather than therapy (all patients with LV dysfunction will be given the same therapy) the difference will relate to as what level of LV impairment this is administered
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
18 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
80 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
1. Patients actively undergoing chemotherapy at increased risk of cardiotoxicity;
use of anthracycline WITH current (but not necessarily concurrent)
trastuzumab (Herceptin) in breast-cancer with the HER2 mutation OR
tyrosine kinase inhibitors (eg sunitinib) OR
cumulative anthracycline dose >450g/m2 of doxorubicin, or equivalent other anthracycline cumulative dose (eg for epirubicin >900g/m2).OR
increased risk of HF (any two of age >65y, type 2 diabetes mellitus, hypertension, previous cardiac injury eg. myocardial infarction)
2. Live within a geographically accessible area for follow-up
3. Are able and willing to provide written informed consent to participate in the study (this includes the ability to communicate fluently with the investigator and that the patient is mentally competent)
除外基準/Key exclusion criteria
1. Unable to provide written informed consent to participate in this study
2. Participating in another clinical research trial where randomized treatment would be unacceptable
3. Valvular stenosis or regurgitation of >moderate severity
4. History of previous heart failure (baseline NYHA >2)
5. Systolic BP <110mmHg
6. Pulse <60/minute
7. Inability to acquire interpretable images (identified from baseline echo)
8. Contraindications/Intolerance to beta blockers or ACE inhibitors
9. Existing therapy with both beta blockers and ACE inhibitors
10. Oncologic (or other) life expectancy <12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial
目標参加者数/Target sample size 320

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム


ミドルネーム
Professor Tom Marwick
所属組織/Organization
Menzies Institute for Medical Research
所属部署/Division name
Cardiao-Metabolic Disease
郵便番号/Zip code
住所/Address
17 Livepool Street, Hobart, TAS, Australia, 7000
電話/TEL +61-3-6226-7703
Email/Email tom.marwick@utas.edu.au

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム


ミドルネーム
Professor Tom Marwick
組織名/Organization
Menzies Institute for Medical Research
部署名/Division name
Cardiao-Metabolic Disease
郵便番号/Zip code
住所/Address
17 Liverpool Street, Hobart, TAS, Australia, 7000
電話/TEL +61-3-6226-7703
試験のホームページURL/Homepage URL
Email/Email tom.marwick@utas.edu.au

実施責任組織/Sponsor
機関名/Institute その他 Menzies Institute for Medical Research
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 GE Medical Systems
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 海外/Outside Japan
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization

住所/Address

電話/Tel
Email/Email

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs はい/YES
試験ID1/Study ID_1 ACTRN12614000341628
ID発行機関1/Org. issuing International ID_1
Australian New Zealand Clinical Trials Registry(ANZCTR)
試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2015 10 20

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 限定募集中/Enrolling by invitation
プロトコル確定日/Date of protocol fixation
2014 01 16
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2014 01 30
フォロー終了(予定)日/Last follow-up date
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2015 10 20
最終更新日/Last modified on
2015 10 21


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000022378
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022378

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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