UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048035 |
|---|---|
| Receipt number | R000054748 |
| Scientific Title | Development of a method for identification of people at high risk of ulcerative colitis by analysis of a large residential cohort. |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2022/12/12 10:31:54 |
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Basic information
Public title
Development of a method for identification of people at high risk of ulcerative colitis by analysis of a large residential cohort.
Acronym
Method for determining risk of ulcerative colitis
Scientific Title
Development of a method for identification of people at high risk of ulcerative colitis by analysis of a large residential cohort.
Scientific Title:Acronym
Method for determining risk of ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We will examine whether early diagnosis of ulcerative colitis by blood autoantibodies is possible using anti-EPCR antibody titer before the onset of ulcerative colitis as the primary endpoint. Furthermore, using samples and information before and after the onset of inflammatory bowel disease, we will conduct metabolomic analysis, proteomic analysis, genomic analysis, and analysis of dietary and lifestyle information to search for risk factors and biomarkers to predict high-risk patients and to develop prediction methods for high-risk patients.
Basic objectives2
Others
Basic objectives -Others
exploratory study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and specificity as the positive rate of autoantibody titers in new onset cases and the ability to diagnose before the onset of disease.
Key secondary outcomes
Genetic and clinical risk factors for pathogenesis of inflammatory bowel diseases
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) Participants of the Tohoku University Tohoku Medical Megabank Organization community cohort and three-generation cohort
(2) Either serum samples or SNP array data are stored.
(3) New cases of inflammatory bowel disease are those who have no history of inflammatory bowel disease (ulcerative colitis or Crohn's disease) on the baseline questionnaire in the cohort study and whose intractable disease application of inflammatory bowel disease was subsequently approved
(4) Cases with a history of inflammatory bowel disease are those with a history of inflammatory bowel disease (ulcerative colitis or Crohn's disease) confirmed in the baseline questionnaire in the cohort study.
Key exclusion criteria
(1) Cases who declined to participate in this study (opt-out cases)
(2) Cases in which the principal investigator determines that the subject is inappropriate for the study (e.g., cases with a large number of missing data and cases in which analysis is extremely difficult)
(3) Cases in which the patient is found to have already died
(4) Cases in which the subject is a withdrawer of consent for a cohort study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Kakuta |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
9808574
Address
1-1 Seiryo Aoba, Sendai, Japan
TEL
0227177171
ykakuta@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Motoi |
| Middle name | |
| Last name | Sawahashi |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
9808574
Address
1-1 Seiryo Aoba, Sendai, Japan
TEL
0227177171
Homepage URL
mt.sawahashi@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2022 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study using existing sample and information
Management information
Registered date
| 2022 | Year | 06 | Month | 12 | Day |
Last modified on
| 2022 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054748
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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