UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043229 |
|---|---|
| Receipt number | R000049330 |
| Scientific Title | Multicenter observational study for evaluating outcomes and prognosis of gastrointestinal diseases based on DPC database |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2025/02/05 09:16:03 |
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Basic information
Public title
Multicenter observational study for evaluating outcomes and prognosis of gastrointestinal diseases based on DPC database
Acronym
Multicenter observational study for evaluating outcomes and prognosis of gastrointestinal diseases based on DPC database
Scientific Title
Multicenter observational study for evaluating outcomes and prognosis of gastrointestinal diseases based on DPC database
Scientific Title:Acronym
Multicenter observational study for evaluating outcomes and prognosis of gastrointestinal diseases based on DPC database
Region
| Japan |
Condition
Condition
gastrointestinal diseases
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aim to evaluated long prognosis and outcomes for gastrointestinal diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
development of several gastrointestinal cancers or several events related to gastrointestinal diseases
Key secondary outcomes
hospitalization period and hospital readmission
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Not applicable
Key exclusion criteria
Not applicable
Target sample size
1500000
Research contact person
Name of lead principal investigator
| 1st name | Nobumi |
| Middle name | |
| Last name | Suzuki |
Organization
Graduate school of medicine, the University of Tokyo
Division name
Department of Gastroenterology,
Zip code
113-8655
Address
7-3-1, Hongo. Bunkyo-ku, Tokyo
TEL
03-3815-5411
nobu3szk@gmail.com
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Niikura |
Organization
Tokyo Medical University
Division name
Gastroenterological Endoscopy
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
rniikura@triton.ocn.ne.jp
Sponsor or person
Institute
Graduate school of medicine, the University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
nothing
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
institutional review boards of the University of Tokyo Hospital
Address
7-3-1, Hongo. Bunkyo-ku, Tokyo
Tel
0338155411
ethics@m.u-tokyo.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Outcomes associated with gastrointestinal diseases
Management information
Registered date
| 2021 | Year | 02 | Month | 02 | Day |
Last modified on
| 2025 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049330
