UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053659 |
|---|---|
| Receipt number | R000061228 |
| Scientific Title | Prospective observational study to analyze the association between the pathogenesis of perforated peptic ulcers and HLA. |
| Date of disclosure of the study information | 2024/02/26 |
| Last modified on | 2024/02/20 14:03:39 |
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Basic information
Public title
HLA and perforated peptic ulcer
Acronym
HLA and perforated peptic ulcer
Scientific Title
Prospective observational study to analyze the association between the pathogenesis of perforated peptic ulcers and HLA.
Scientific Title:Acronym
Prospective observational study to analyze the association between the pathogenesis of perforated peptic ulcers and HLA.
Region
| Japan |
Condition
Condition
Peptic ulcer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
1. Why do some patients with ulcers perforate and others not?
2. HLA may associate the pathogenesis of perforated ulcers.
3. Exploratory research of predictors for perforated ulcers.
Basic objectives2
Others
Basic objectives -Others
Clinical characteristics, HLA, HLA-relevant peptides, subsequent gastric cancer in the remnant stomach
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical risk factors between peptic ulcer patients who perforated and not and HLA.
Key secondary outcomes
Ulcer recurrence, subsequent gastric cancer and multiple primary malignancy.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Perforated peptic ulcers and non-perforated peptic ulcers whose HLA was measured, including cases in which prior treatment and diagnosis (endoscopy, etc.) were confirmed.
Key exclusion criteria
NP
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Toshi |
| Middle name | |
| Last name | Mitomi |
Organization
Tokai University
Division name
Department of Surgery
Zip code
259-1193
Address
Bohseidai, Isehara, Kanagawa, Japan.
TEL
0463-96-6163
ogoshik@gmail.com
Public contact
Name of contact person
| 1st name | Kyoji |
| Middle name | |
| Last name | Ogoshi |
Organization
Tokai University
Division name
Department of Surgery
Zip code
259-1193
Address
Bohseidai, Isehara, Kanagawa, Japan.
TEL
0463-96-6163
Homepage URL
ogoshik@gmail.com
Sponsor or person
Institute
Study Group for Gastroenterological Disease
Institute
Department
Personal name
Funding Source
Organization
Study Group for Gastroenterological Disease
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
Study Group for Gastroenterological Disease
Address
4-2-28 Kudan-kita, Chiyoda-ku, Tokyo, 102-0073, Japan
Tel
03-6261-0245
office@ace-enterprise.net
Secondary IDs
Secondary IDs
YES
Study ID_1
11R-127,128
Org. issuing International ID_1
Tokai University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
See https://www.jstage.jst.go.jp/article/acrt/31/2/31_42/_article/-char/ja
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/acrt/31/2/31_42/_article/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/acrt/31/2/31_42/_article/-char/ja
Number of participants that the trial has enrolled
422
Results
1. Patients with (n = 303) and without (n = 119) PPU recruited from our member hospitals and more likely to have duodenal ulcers, young, consume alcohol, and smoke. There was no significant difference in sex and ulcer recurrence. Perforated peptic ulcer patients and patients who underwent vagotomy decreased risks of cancer development.
2. Patients harboring HLA-Cw1 and -Cw7 and their heterozygotes protected against PPU development, whereas HLA-Cw3 reduced cancer development.
Results date posted
| 2024 | Year | 02 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 07 | Month | 28 | Day |
Baseline Characteristics
See https://www.jstage.jst.go.jp/article/acrt/31/2/31_42/_article/-char/ja
Participant flow
See https://www.jstage.jst.go.jp/article/acrt/31/2/31_42/_article/-char/ja
Adverse events
NP
Outcome measures
See https://www.jstage.jst.go.jp/article/acrt/31/2/31_42/_article/-char/ja
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 1977 | Year | 12 | Month | 01 | Day |
Date of IRB
| 1977 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 1977 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2007 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The principles of this study outlined in the Declaration of Helsinki were followed. As T. Mitomi passed away, an e-mail address of the principal investigator is that of K. Ogoshi.
Management information
Registered date
| 2024 | Year | 02 | Month | 20 | Day |
Last modified on
| 2024 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061228
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/02/20 | 潰瘍UMIN登録提出.xlsx |
