UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053638 |
|---|---|
| Receipt number | R000061209 |
| Scientific Title | Analysis of the Causes and Prognostic Factors of Unexplained Gastrointestinal Bleeding |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2025/04/01 07:56:25 |
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Basic information
Public title
Analysis of the Causes and Prognostic Factors of Unexplained Gastrointestinal Bleeding
Acronym
Analysis of the Causes and Prognostic Factors of Unexplained Gastrointestinal Bleeding
Scientific Title
Analysis of the Causes and Prognostic Factors of Unexplained Gastrointestinal Bleeding
Scientific Title:Acronym
Analysis of the Causes and Prognostic Factors of Unexplained Gastrointestinal Bleeding
Region
| Japan |
Condition
Condition
Obscure Gastro-Intestinal Bleeding(OGIB)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the prognosis of OGIB patients who underwent capsule endoscopy
Basic objectives2
Others
Basic objectives -Others
To determine the association between prognosis and nutritional status, sarcopenia, and anemia in OGIB cases
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hazard ratios for each factor with death as the event in OGIB cases
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. CE performed with a diagnosis of OGIB
2. Those who have not received a refusal to participate in this research from the research subject or from a person who can represent the research subject's wishes and interests.
Key exclusion criteria
Persons deemed inappropriate as research subjects by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shoko |
| Middle name | |
| Last name | Ono |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
060-8648
Address
kita 14 jo, nishi 5 chome, kita-ku, Sapporo, Hokkaido 060-8648, Japan
TEL
+81-11-716-116
onosho@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Inoue |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
060-8648
Address
kita 14 jo, nishi 5 chome, kita-ku, Sapporo, Hokkaido 060-8648, Japan
TEL
+81-11-716-116
Homepage URL
mokomokomomon@gmail.com
Sponsor or person
Institute
Hokkaido 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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
kita 14 jo, nishi 5 chome, kita-ku, Sapporo, Hokkaido 060-8648, Japan
Tel
+81-11-706-7636
crjimu@huhp.hokudai.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
| 2024 | Year | 03 | 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
99
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
Completed
Date of protocol fixation
| 2024 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Hazard ratios will be calculated in a univariate analysis using the Cox proportional hazards model for items such as CE findings, background disease, and medications from diagnosis to the date of death event or censoring date. Since there are no existing reports on factors associated with mortality, factors that are significant in univariate analysis are analyzed in multivariate analysis. Hazard ratios are expressed using 95% confidence intervals with a significance level of 5% bilaterally.
The obtained risk factors are stratified and presented as Kaplan-Meier curves, and the 5-year survival rates are compared.
Percentages and summary statistics are calculated as appropriate.
Management information
Registered date
| 2024 | Year | 02 | Month | 18 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061209
