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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035134
Receipt No. R000040041
Scientific Title Prospective observational study of endoscopic resection for early gastrointestinal neoplasms
Date of disclosure of the study information 2019/01/01
Last modified on 2019/04/02

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Basic information
Public title Prospective observational study of endoscopic resection for early gastrointestinal neoplasms
Acronym KEIO-GI study
Scientific Title Prospective observational study of endoscopic resection for early gastrointestinal neoplasms
Scientific Title:Acronym KEIO-GI study
Region
Japan

Condition
Condition Early gastrointestinal neoplasms
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the feasibility of endoscopic resection for early gastrointestinal neoplasms
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Five-year relapse-free survival rate
Key secondary outcomes Procedure success rate, En bloc resection rate, Pathological diagnosis, Complications, Procedure time, Amount of bleeding, Three-year relapse-free survival rate, Relapse-free survival time, Three or five-year overall survival rate, Quality of life after procedure, Medical care cost

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who undergo endoscopic resection for early gastrointestinal neoplasms
Key exclusion criteria Patients whose lesions were found to be outside the adaptation for endoscopic resection
Target sample size 1500

Research contact person
Last name of lead principal investigator
1st name Kato
Middle name
Last name Motohiko
Organization Keio University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3437
Email motohikokato@keio.jp

Public contact
1st name of contact person
1st name Kiguchi
Middle name
Last name Yoshiyuki
Organization Keio University School of Medicine
Division name Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3437
Homepage URL
Email kiguchiyoshiyuki@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Research ethics committee, Keio University School of Medicine
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
Tel 0333531211
Email med-rinri-jimu@adst.keio.ac.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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 11 Month 19 Day
Date of IRB
2018 Year 12 Month 12 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
2029 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: Prospective observational study
Aim: To clarify the feasibility of endoscopic resection for early gastrointestinal neoplasms

Management information
Registered date
2018 Year 12 Month 04 Day
Last modified on
2019 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040041

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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