UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035134 |
|---|---|
| Receipt number | 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 16:33:48 |
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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
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
motohikokato@keio.jp
Public contact
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
kiguchiyoshiyuki@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040041
