UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041268 |
|---|---|
| Receipt number | R000047115 |
| Scientific Title | A prospective study on comprehensive sampling to search exacerbation factors and efficacy predictors in patients with autoimmune and immune related disease |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2020/07/31 16:33:35 |
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Basic information
Public title
A prospective study on comprehensive sampling to search exacerbation factors and efficacy predictors in patients with autoimmune and immune related disease
Acronym
comprehensive sampling in patients with autoimmune and immune related disease
Scientific Title
A prospective study on comprehensive sampling to search exacerbation factors and efficacy predictors in patients with autoimmune and immune related disease
Scientific Title:Acronym
comprehensive sampling in patients with autoimmune and immune related disease
Region
| Japan |
Condition
Condition
Patients with autoimmune/immune-related diseases such as ulcerative colitis, Crohn's disease, Bechet disease, immune-check point inhibitor related colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate biomarkers applicable to daily medical care by comprehensive sampling from patients with autoimmune and immune related diseases.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Expression of inflammatory cytokines in the intestinal tract, analysis of intestinal bacterial flora, measurement of fecal metabolites, identification of disease susceptibility genes
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
1. Patients who meet the diagnostic criteria for each disease
2. Patients who obtained written consent
Key exclusion criteria
1. Patients who have not confirmed the diagnosis
2. Patients who do not get written consent
3. Patients who the doctor judges as inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nakase |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8543
Address
S-1, W-16, Chuo-ku, Sapporo, 060-8543 Japan
TEL
0116112111
hiropynakase@gmail.com
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Yokoyama |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8543
Address
S-1, W-16, Chuo-ku, Sapporo, 060-8543 Japan
TEL
0116112111
Homepage URL
yoshi_yokoyamaa@yahoo.co.jp
Sponsor or person
Institute
Sapporo Medical 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
Sapporo Medical University School of Medicine
Address
S-1, W-16, Chuo-ku, Sapporo, 060-8543 Japan
Tel
0116112111
ji-rskk@sapmed.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
| 2020 | Year | 08 | 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
| 2019 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2020 | Year | 07 | Month | 31 | Day |
Last modified on
| 2020 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047115
