UMIN-CTR 臨床試験登録情報の閲覧

BACK TOP
UMIN-CTR ホーム 用語の説明(簡易版) 用語の説明(詳細版)--準備中 FAQ

利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000001057
受付番号 R000001271
科学的試験名 早期胃癌内視鏡治療後、H. pylori除菌後胃粘膜のサーベイランス
一般公開日(本登録希望日) 2008/02/27
最終更新日 2015/09/02

※ 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 早期胃癌内視鏡治療後、H. pylori除菌後胃粘膜のサーベイランス Surveillance for early gastric cancer after endoscopic submucosal dissection and H.pylori eradication.
一般向け試験名略称/Acronym 早期胃癌内視鏡治療後のサーベイランス Surveillance for early gastric cancer after endoscopic submucosal dissection.
科学的試験名/Scientific Title 早期胃癌内視鏡治療後、H. pylori除菌後胃粘膜のサーベイランス Surveillance for early gastric cancer after endoscopic submucosal dissection and H.pylori eradication.
科学的試験名略称/Scientific Title:Acronym 早期胃癌内視鏡治療後のサーベイランス Surveillance for early gastric cancer after endoscopic submucosal dissection.
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 早期胃癌 Early gastric cancer
疾患区分1/Classification by specialty
消化器内科学(消化管)/Gastroenterology
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 胃癌が発生する原因を調べ、将来的には新たな治療法を開発することを目的とする。 The aim of this study is to elucidate the molecular mechanism of gastric carcinogenesis and develop the new therapeutic approach of gastric cancer.
目的2/Basic objectives2 生物学的・臨床的同等性/Bio-equivalence
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 早期胃癌内視鏡治療後の胃癌再発の有無と
早期胃癌や背景胃粘膜(萎縮・腸上皮化生粘膜など)におけるDNAメチル化異常、DNA、マイクロRNA、蛋白質 (CD44v9、CagA、幹細胞性関連因子など) の発現異常
Recurrence of gastric cancer after endoscopic submucosal dissection and Aberrant DNA methylation and aberrant expression of microRNAs, DNA, and proteins, including CD44v9, CagA and stemness-related factors, in gastric tumors and in background gastric mucosa such as atrophic and metaplastic mucosa
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
20 歳/years-old 以上/<=
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 早期胃癌と診断され内視鏡的粘膜下層剥離術の適応と考えられる症例。 Patients who were diagnosed as early gastric cancer and are considered as the indication of endoscopic submucosal dissection.
除外基準/Key exclusion criteria 抗凝固剤・抗血小板剤を内服中の症例
内視鏡治療後経過観察中に胃癌の再発などで外科手術(胃全摘出術)が施行された症例
H. pylori除菌治療を二次除菌まで施行して陰性化しなかった症例
Patients who have anticoagulant therapy.
Patients who had total gastrectomy during the course observation.
Patients who do not respond to 2nd eradication thrapy of H.pylori.
目標参加者数/Target sample size 100

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

ミドルネーム
鈴木 秀和

ミドルネーム
Hidekazu Suzuki
所属組織/Organization 慶應義塾大学医学部 Keio University, School of Medicine
所属部署/Division name 消化器内科 Division of Gastroenterology and Hepatology
郵便番号/Zip code
住所/Address 東京都新宿区信濃町35 35 Shinanomachi, Shinjuku-ku, Tokyo
電話/TEL 03-5363-3914
Email/Email hsuzuki@a6.keio.jp

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
鈴木 秀和

ミドルネーム
Hidekazu Suzuki
組織名/Organization 慶應義塾大学医学部 Keio University, School of Medicine
部署名/Division name 消化器内科 Division of Gastroenterology and Hepatology
郵便番号/Zip code
住所/Address 新宿区信濃町35 35 Shinanomachi, Shinjuku-ku, Tokyo
電話/TEL 03-5363-3914
試験のホームページURL/Homepage URL
Email/Email hsuzuki@a6.keio.jp

実施責任組織/Sponsor
機関名/Institute その他 Keio University, School of Medicine
機関名/Institute
(機関選択不可の場合)
慶應義塾大学医学部
部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Division of Gastroenterology and Hepatology, Keio University, School of Medicine
機関名/Organization
(機関選択不可の場合)
慶應義塾大学医学部消化器内科
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
2008 02 27

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.nature.com/bjc/journal/v109/n2/full/bjc2013314a.html
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results
British Journal of Cancer (2013) 109, 379-386. doi:10.1038/bjc.2013.314 www.bjcancer.com
BACKGROUND: 
Multiple early gastric cancers (EGCs) may develop in 6-14% of patients even after achieving curative endoscopic submucosal dissection (ESD); however, a useful biomarker for predicting recurrence is not available. The present study investigated whether the expression of CD44 variant 9 (CD44v9), a functional cancer stem cell marker, in the primary gastric cancer tissue represents an indicator of recurrence.

METHODS: 
Eighty-eight patients who underwent ESD for EGC from 2008 to 2010 were enrolled and monitored for recurrence for 3 years. The expression levels of CD44v9 in the tissue of initial EGCs were evaluated by immunohistochemistry, and the recurrence rate was compared between CD44v9-positive and CD44v9-negative groups. The mucin phenotype and expression of microRNA-21 (miR-21) and programmed cell death protein 4 (PDCD4) were also analysed.

RESULTS: 
The recurrence rate of EGC was significantly higher in the CD44v9-positive group than in the CD44v9-negative group (hazard ratio (HR), 21.8; 95% confidence interval (CI), 5.71-83.1). However, mucin phenotypes and the expression of miR-21 and PDCD4 did not predict recurrence after ESD. Meanwhile, grade of gastric atrophy was also identified as a significant marker of multiple recurrence (HR, 4.95; 95% CI, 1.30-18.8).

CONCLUSION: 
CD44 variant 9 expression represents a potential predictive marker for recurrence in EGC.
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
2008 02 04
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
2008 02 01
フォロー終了(予定)日/Last follow-up date
2016 11 30
入力終了(予定)日/Date of closure to data entry
2017 01 31
データ固定(予定)日/Date trial data considered complete
2017 03 31
解析終了(予定)日/Date analysis concluded
2017 03 31

その他/Other
その他関連情報/Other related information 早期胃癌内視鏡治療後の胃癌再発の有無
胃癌や背景胃粘膜におけるDNAメチル化異常やマイクロRNA、蛋白質(CD44v9、CagAなど)の発現異常


Saito Y, Suzuki H, Imaeda H, Matsuzaki J, Hirata K, Tsugawa H, Hibino S, Kanai
Y, Saito H, Hibi T. The tumor suppressor microRNA-29c is downregulated and
restored by celecoxib in human gastric cancer cells. Int J Cancer. 2013 Apr
15;132(8):1751-60. doi: 10.1002/ijc.27862. Epub 2012 Oct 17. PubMed PMID:
23001726.
http://onlinelibrary.wiley.com/doi/10.1002/ijc.27862/abstract
Recurrence of gastric cancer after endoscopic submucosal dissection
Aberrant DNA methylation and aberrant expression of microRNAs and proteins, including CD44v9 and CagA, in gastric tumors and epithelial tissues

MicroRNAs (miRNAs) are small noncoding RNAs that function as endogenous silencers of target genes and play critical roles during carcinogenesis. The selective cyclooxygenase-2 (COX-2) inhibitor celecoxib has been highlighted as a potential drug for treatment of gastrointestinal tumors. The aim of this study was to investigate the role of miRNAs in gastric carcinogenesis and the feasibility of a new therapeutic approach for gastric cancer. miRNA expression profiles were examined in 53 gastric tumors including gastric adenomas (atypical epithelia), early gastric cancers and advanced gastric cancers and in gastric cancer cells treated with celecoxib. miRNA microarray analysis revealed that miR-29c was significantly downregulated in gastric cancer tissues relative to nontumor gastric mucosae. miR-29c was significantly activated by celecoxib in gastric cancer cells. Downregulation of miR-29c was associated with progression of gastric cancer and was more prominent in advanced gastric cancers than in gastric adenomas and early gastric cancer. In addition, expression of the oncogene Mcl-1, a target of miR-29c, was significantly increased in gastric cancer tissues relative to nontumor gastric mucosae. Activation of miR-29c by celecoxib induced suppression of Mcl-1 and apoptosis in gastric cancer cells. These results suggest that downregulation of the tumor suppressor miR-29c plays critical roles in the progression of gastric cancer. Selective COX-2 inhibitors may have clinical promise for the treatment of gastric cancer via restoration of miR-29c.

管理情報/Management information
登録日時/Registered date
2008 02 27
最終更新日/Last modified on
2015 09 02


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=R000001271
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001271

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


UMIN臨床試験登録システムのご使用に関するお問い合わせは、こちらのお問い合わせフォーム からお願いいたします。それ以外のお問い合わせは、 こちら よりお願い致します。