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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023804
Receipt No. R000027156
Scientific Title Endoscopic submucosal dissection appropriate interval observation study
Date of disclosure of the study information 2016/08/29
Last modified on 2019/09/02

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Basic information
Public title Endoscopic submucosal dissection appropriate interval observation study
Acronym AI study
Scientific Title Endoscopic submucosal dissection appropriate interval observation study
Scientific Title:Acronym AI study
Region
Japan

Condition
Condition early gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 After endoscopic submucosal dissection (ESD) for gastric cancer, to clarify the appropriate endoscopic test interval in order to discover the metachronous gastric cancer in endoscopic therapy adaptive.
Basic objectives2 Others
Basic objectives -Others After early gastric cancer ESD, metachronous gastric cancer at a constant rate is for generating, regular endoscopy is performed. Usually, as surveillance of stomach cancer that occurs in metachronous, is often carried out every 12 months, it has been found beyond the endoscopic healing adaptation with 0-15% of metachronous gastric cancer. So we, the interval at which to implement the upper gastrointestinal endoscopy after ESD test for gastric cancer is assigned to 6 months and 12 months do the prospective study, found in the off-label of endoscopic therapy by reducing the inspection interval It is possible to reduce the frequency of occurrence of metachronous gastric cancer to examine whether it is possible that.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Occurrence rate of metachronous gastric cancer to be found beyond the endoscopic therapy adaptation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 After endoscopic curative resection of gastric cancer, performed upper gastrointestinal endoscopy and every 6 months to 5 years.
Interventions/Control_2 After endoscopic curative resection of gastric cancer, performed upper gastrointestinal endoscopy and every 12 months to 5 years.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who have been determined to curative resection with endoscopic therapy for the initial of early gastric cancer (adenocarcinoma).
Key exclusion criteria Patients who have received a treatment of gastric cancer in the past. In addition to endoscopic resection healing lesions, patients with different tumor lesions. Patients with gastric adenoma. Patients with surgical esophagus and stomach resection history. Others, patients principal investigator and research personnel was judged to be inappropriate as a target.
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Shuichi
Middle name
Last name Kaneko
Organization Kanazawa University
Division name Department of gastroenterology
Zip code 920-8641
Address 13-1,Takaramachi,Kanazawa
TEL 076-265-2235
Email skaneko@m-kanazawa.jp

Public contact
Name of contact person
1st name Hajime
Middle name
Last name Takatori
Organization Kanazawa University
Division name Department of gastroenterology
Zip code 920-8641
Address 13-1, Takara-machi, Kanazawa
TEL 076-265-2235
Homepage URL
Email takatori@m-kanazawa.jp

Sponsor
Institute Hokuriku branch of Japan Gastroenterological Endoscopy Society
Institute
Department

Funding Source
Organization Hokuriku Branch of Japan Gastroenterological Endoscopy Society
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization iCREK
Address 13-1, Takara-machi, Kanazawa
Tel 076-265-2090
Email crc.irb-knz@esct.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 金沢大学附属病院、金沢医科大学病院、石川県立中央病院、公立松任石川中央病院、市立砺波総合病院、福井県立病院、金沢医療センター、富山県立中央病院、小松市民病院、福井県済生会病院、やわたメディカルセンター、恵寿総合病院、富山市民病院、公立能登総合病院、公立羽咋病院、市立敦賀病院、金沢市立病院、金沢赤十字病院、福井赤十字病院、済生会金沢病院、浅ノ川病院

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 29 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 08 Month 26 Day
Date of IRB
2016 Year 07 Month 28 Day
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2026 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 29 Day
Last modified on
2019 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027156

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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