UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038548 |
|---|---|
| Receipt number | R000043909 |
| Scientific Title | Observational study on the effectiveness and validity of treatment for upper gastrointestinal diseases |
| Date of disclosure of the study information | 2019/11/12 |
| Last modified on | 2019/11/11 22:44:04 |
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Basic information
Public title
Observational study on the effectiveness and validity of treatment for upper gastrointestinal diseases
Acronym
Observational study on the effectiveness and validity of treatment for upper gastrointestinal diseases
Scientific Title
Observational study on the effectiveness and validity of treatment for upper gastrointestinal diseases
Scientific Title:Acronym
Observational study on the effectiveness and validity of treatment for upper gastrointestinal diseases
Region
| Japan |
Condition
Condition
upper gastrointestinal diseases
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the background, surgical outcome, and postoperative corase of patients who had treated for upper gastrointestinal (esophagus, stomach,and duodenum) disease in our departoment. In addition, we aim to improve our treatment by verifying the validity and effectiveness of past treatment methods.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is related to the validity and prognosis of our treatment, but the specific items are diverse.
Key secondary outcomes
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 treated at Fujita Health University (department of surgery)
Key exclusion criteria
none
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Uyama |
Organization
Fujita Health University
Division name
Surgery
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, 470-1192 Japan.
TEL
+81-562-93-9254
iuyama@mac.com
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Kikuchi |
Organization
Fujita Health University
Division name
Surgery
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, 470-1192 Japan
TEL
+81-562-93-9254
Homepage URL
kikuken0414@gmail.com
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
none
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
Fujita Health University Institutional Review Board
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, 470-1192 Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2019 | Year | 11 | Month | 12 | 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
| 2019 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective observational study will be conducted for patients with upper gastrointestinal diseases treated at Fujita Health University (department of surgery) since 1997. We will collect the date of patients backgrounds,treatments, surgical outcome including surgical procedures and postoperative coarse. After that, we evaluate their impact on prognosis and the validity of our treatment. Specifically, their medical records, blood test, image, pathology, etc. will be examined and statistically analyzed.If necessary, we will conduct interviews with patients. We take care to avoid compulsion on patients during interviews.
Management information
Registered date
| 2019 | Year | 11 | Month | 11 | Day |
Last modified on
| 2019 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043909
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
