UMIN-CTR Clinical Trial

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
Email	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
Email	mt.sawahashi@gmail.com

Sponsor
Institute	Tohoku University
Institute
Department

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
Email	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
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 06 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054748

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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