UMIN-CTR 臨床試験登録情報の閲覧

基本情報/Basic information
試験名/Official scientific title of the study	The Tianjin Chronic Low-grade Systemic Inflammation and Health Cohort Study	The Tianjin Chronic Low-grade Systemic Inflammation and Health Cohort Study
試験簡略名/Title of the study (Brief title)	TCLSIH	TCLSIH or TCLSIHealth
試験実施地域/Region	アジア（日本以外）/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition	心血管疾患と癌	cardiovascular diseases and cancer
疾患区分1/Classification by specialty	内科学一般/Medicine in general 循環器内科学/Cardiology 老年内科学/Geriatrics 成人/Adult
疾患区分2/Classification by malignancy	悪性腫瘍/Malignancy
ゲノム情報の取扱い/Genomic information	はい/YES

目的/Objectives
目的1/Narrative objectives1	慢性炎症と生活習慣病予防	The study was focused on the relationship between chronic low-grade systemic inflammation and the health status.
目的2/Basic objectives2	その他/Others
目的2 -その他詳細/Basic objectives -Others	ライフスタイルと生活習慣病予防	lifestyles and chronic diseases prevention
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	心血管疾患と癌の発生	incidence of cardiovascular diseases and cancer
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	観察/Observational

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	18 歳/years-old 以上/<=
年齢（上限）/Age-upper limit	100 歳/years-old 以下/>=
性別/Gender	男女両方/Male and Female
選択基準/Key inclusion criteria	Participants, who had received health examinations and had completed questionnaires regarding their lifestyles.	Participants, who had received health examinations and had completed questionnaires regarding their lifestyles.
除外基準/Key exclusion criteria	cardiovascular diseases and cancer	cardiovascular diseases and cancer
目標参加者数/Target sample size	100000

責任研究者/Research contact person
責任研究者名/Name of lead principal investigator	Kaijun Niu	Kaijun Niu
所属組織/Organization	Nutritional Epidemiology Institute and School of Public Health, Tianjin Medical University, Tianjin, China.	Nutritional Epidemiology Institute and School of Public Health, Tianjin Medical University, Tianjin, China.
所属部署/Division name	Nutritional Epidemiology Institute	Nutritional Epidemiology Institute
住所/Address	22 Qixiangtai Road, Heping District, Tianjin 300070, China.	22 Qixiangtai Road, Heping District, Tianjin 300070, China.
電話/TEL	+86-22-83336613
Email/Email	nkj0809@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名/Name of contact person	Kaijun Niu	Kaijun Niu
組織名/Organization	Nutritional Epidemiology Institute and School of Public Health, Tianjin Medical University, Tianjin,	Nutritional Epidemiology Institute and School of Public Health, Tianjin Medical University, Tianjin,
部署名/Division name	Nutritional Epidemiology Institute	Nutritional Epidemiology Institute
住所/Address	22 Qixiangtai Road, Heping District, Tianjin 300070, China.	22 Qixiangtai Road, Heping District, Tianjin 300070, China.
電話/TEL	+86-22-83336613
試験のホームページURL/Homepage URL
Email/Email	nkj0809@gmail.com

実施責任組織/Sponsor
機関名/Institute	その他	Tianjin Medical University, Tianjin, China.
機関名/Institute （機関選択不可の場合）	Tianjin Medical University, Tianjin, China.
部署名/Department

研究費提供組織/Funding Source
機関名/Organization	その他	National Natural Science Foundation of China
機関名/Organization （機関選択不可の場合）	National Natural Science Foundation of China
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)

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	2017 年 05 月 01 日

試験進捗状況/Progress
試験進捗状況/Recruitment status	一般募集中/Open public recruiting
プロトコル確定日/Date of protocol fixation	2013 年 03 月 01 日
登録・組入れ開始（予定）日/Anticipated trial start date	2013 年 05 月 29 日
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

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	中間解析等の途中公開/Partially published
結果掲載URL/URL releasing results
主な結果/Results
その他関連情報/Other related information	There were 50,000 participants who had received at least one health examination.	There were 50,000 participants who had received at least one health examination.

管理情報/Management information
登録日時/Registered date	2017 年 04 月 28 日
最終更新日/Last modified on	2017 年 04 月 28 日

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=R000031137
URL(英語)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031137