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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000018145
受付番号 R000021017
科学的試験名 間質性肺炎合併進行非小細胞肺癌に対する化学療法:系統的レビューとメタアナリシス
一般公開日(本登録希望日) 2015/07/01
最終更新日 2016/12/31

※ 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 間質性肺炎合併進行非小細胞肺癌に対する化学療法:系統的レビューとメタアナリシス Chemotherapy for advanced non-small cell lung cancer with interstitial lung disease: systematic review and meta-analysis
一般向け試験名略称/Acronym 間質性肺炎合併非小細胞肺癌に対する化学療法:系統的レビューとメタアナリシス Chemotherapy for advanced non-small cell lung cancer with interstitial lung disease: systematic review and meta-analysis
科学的試験名/Scientific Title 間質性肺炎合併進行非小細胞肺癌に対する化学療法:系統的レビューとメタアナリシス Chemotherapy for advanced non-small cell lung cancer with interstitial lung disease: systematic review and meta-analysis
科学的試験名略称/Scientific Title:Acronym 間質性肺炎合併非小細胞肺癌に対する化学療法:系統的レビューとメタアナリシス Chemotherapy for advanced non-small cell lung cancer with interstitial lung disease: systematic review and meta-analysis
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 間質性肺炎を合併した進行非小細胞肺癌 advanced non-small cell lung cancer with interstitial lung disease
疾患区分1/Classification by specialty
内科学一般/Medicine in general 呼吸器内科学/Pneumology
血液・腫瘍内科学/Hematology and clinical oncology
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 間質性肺炎合併進行非小細胞肺癌への化学療法の有効性と安全性について現存するエビデンスをまとめる The research question of this review is: what are the clinical effectiveness and safety of chemotherapy for treating NSCLC with ILD ?
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others 系統的レビューとメタ・アナリシス Sytematic review and mata-analysis
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 1年生存率 One year survival
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 その他・メタアナリシス等/Others,meta-analysis etc

試験デザイン/Study design
基本デザイン/Basic design
ランダム化/Randomization
ランダム化の単位/Randomization unit
ブラインド化/Blinding
コントロール/Control
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
介入の目的/Purpose of intervention
介入の種類/Type of intervention
介入1/Interventions/Control_1

介入2/Interventions/Control_2

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

適用なし/Not applicable
年齢(上限)/Age-upper limit

適用なし/Not applicable
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria 間質性肺炎合併進行非小細胞肺癌
化学療法で治療された
Patients with interstitial lung disease and suffering from non small cell lung cancer.
Treated with chemotherapy.
除外基準/Key exclusion criteria epidermal growth factor receptor tyrosine-kinase inhibitorで治療された treated with epidermal growth factor receptor tyrosine-kinase inhibitor
目標参加者数/Target sample size 200

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

ミドルネーム
片岡裕貴

ミドルネーム
KATAOKA Yuki
所属組織/Organization 兵庫県立尼崎総合医療センター Hyogo Prefectural Amagasaki General Medical Center
所属部署/Division name 呼吸器内科・臨床研究推進ユニット Department of Respiratory Medicine, Hospital Care Research Unit
郵便番号/Zip code
住所/Address 兵庫県尼崎市東難波町2-17-77 Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo 660-0892, Japan.
電話/TEL 06-6480-7000
Email/Email hanshin.crt@gmail.com

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
片岡裕貴

ミドルネーム
KATAOKA Yuki
組織名/Organization 兵庫県立尼崎総合医療センター Hyogo Prefectural Amagasaki General Medical Center
部署名/Division name 呼吸器内科・臨床研究推進ユニット Department of Respiratory Medicine, Hospital Care Research Unit
郵便番号/Zip code
住所/Address 兵庫県尼崎市東難波町2-17-77 Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo 660-0892, Japan.
電話/TEL 06-6480-7000
試験のホームページURL/Homepage URL
Email/Email hanshin.crt@gmail.com

実施責任組織/Sponsor
機関名/Institute その他 Hyogo Prefectural Amagasaki General Medical Center
機関名/Institute
(機関選択不可の場合)
兵庫県立尼崎総合医療センター
部署名/Department

研究費提供組織/Funding Source
機関名/Organization 自己調達 Hyogo Prefectural Amagasaki General Medical Center
機関名/Organization
(機関選択不可の場合)
兵庫県立尼崎総合医療センター
組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
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 いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

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 07 01

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 最終結果が公表されている/Published

結果/Result
結果掲載URL/URL related to results and publications http://www.haigan.gr.jp/journal/am/2015a/15a_gpl31000P-184.html
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 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2015 04 10
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
2015 05 01
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 Searches
The full search strategy is not required, but may be supplied as a link or attachment.
We sill search the following electronic databases; 1. MEDLINE; 2. EMBASE via SCOPUS; 3. Cochrane library; 4. ICHUSHI Web; In addition we will searche the following websites: 1. ClinicalTrials.gov 2. the World Health Organization International Clinical Trials Platform Search Portal ( ICTRP) All relevant studies published as an article, and country of origin will be included. We will exclude studies reporting on < 10 participants.



Types of study to be included initially
irrespective of types of study design (observational or interventional)

Primary outcome(s)
One year survival
Measured by proportion of the total number of patients dying from any cause within one year after the initiation of therapy.
Secondary outcomes
Acute excercerbation of ILD during the study period
AE-ILD was defined by original authors. Measured by proportion of the total number of patients suffered AE-ILD during the study period.

Data extraction, (selection and coding)
Give the procedure for selecting studies for the review and extracting data, including the number of researchers involved and how discrepancies will be resolved. List the data to be extracted.

Risk of bias (quality) assessment
Two authors independently will assess risk of bias used the Newcastle-Ottawa scale for observational studies and the Cochrane risk of bias table for interventional studies . Agreement between the two review authors with regard to the primary outcomes and the risk of bias items will be reported as percentage agreement and weighted kappa. Disagreement will be resolved by discussion and if necessary a third review author involved.

Strategy for data synthesis
We will pool the relative risk (RR) with 95% confidence interval (CI) for the following binary outcomes.

Analysis of subgroups or subsets
None planned
Searches
The full search strategy is not required, but may be supplied as a link or attachment.
We sill search the following electronic databases; 1. MEDLINE; 2. EMBASE via SCOPUS; 3. Cochrane library; 4. ICHUSHI Web; In addition we will searche the following websites: 1. ClinicalTrials.gov 2. the World Health Organization International Clinical Trials Platform Search Portal ( ICTRP) All relevant studies published as an article, and country of origin will be included. We will exclude studies reporting on < 10 participants.



Types of study to be included initially
irrespective of types of study design (observational or interventional)

Primary outcome(s)
One year survival
Measured by proportion of the total number of patients dying from any cause within one year after the initiation of therapy.
Secondary outcomes
Acute excercerbation of ILD during the study period
AE-ILD was defined by original authors. Measured by proportion of the total number of patients suffered AE-ILD during the study period.

Data extraction, (selection and coding)
Give the procedure for selecting studies for the review and extracting data, including the number of researchers involved and how discrepancies will be resolved. List the data to be extracted.

Risk of bias (quality) assessment
Two authors independently will assess risk of bias used the Newcastle-Ottawa scale for observational studies and the Cochrane risk of bias table for interventional studies . Agreement between the two review authors with regard to the primary outcomes and the risk of bias items will be reported as percentage agreement and weighted kappa. Disagreement will be resolved by discussion and if necessary a third review author involved.

Strategy for data synthesis
We will pool the relative risk (RR) with 95% confidence interval (CI) for the following binary outcomes.

Analysis of subgroups or subsets
None planned

管理情報/Management information
登録日時/Registered date
2015 07 01
最終更新日/Last modified on
2016 12 31


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=R000021017
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021017

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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