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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036203
Receipt No. R000041242
Scientific Title Establishment of epigenetic approach to identify high risk patients of colorectal cancer in ulcerative colitis
Date of disclosure of the study information 2019/03/15
Last modified on 2019/03/14

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Basic information
Public title Establishment of epigenetic approach to identify high risk patients of colorectal cancer in ulcerative colitis
Acronym Identifying high risk patients of colorectal cancer in ulcerative colitis
Scientific Title Establishment of epigenetic approach to identify high risk patients of colorectal cancer in ulcerative colitis
Scientific Title:Acronym Identifying high risk patients of colorectal cancer in ulcerative colitis
Region
Japan

Condition
Condition Ulcerative Colitis
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 DNA methylation analysis in rectal mucosa from ulcerative colitis patients for evaluating the risk of colorectal cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Diagnostic accuracy of DNA methylation analysis for ulcerative colitis patients complicated with colorectal cancer using rectal mucosa from ulcerative colitis
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 Longstanding ulcerative colitis patients who need screening colonoscopy
Key exclusion criteria Ulcerative patients less than 20 years
Ulcerative patients without ability for judgment
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Yuji
Middle name
Last name Toiyama
Organization Division of Reparative Medicine, Institute of Life Sciences, Mie University Graduate School of Medicine
Division name Department of Gastrointestinal and Pediatric Surgery
Zip code 514-8507
Address 2-174 Edobashi Tsu Mie
TEL 059-232-1111
Email ytoi0725@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Yuji
Middle name
Last name Toiyama
Organization Division of Reparative Medicine, Institute of Life Sciences, Mie University Graduate School of Medic
Division name Department of Gastrointestinal and Pediatric Surgery
Zip code 514-8507
Address 2-174 Edobashi Tsu Mie
TEL 059-232-1111
Homepage URL
Email ytoi0725@clin.medic.mie-u.ac.jp

Sponsor
Institute Division of Reparative Medicine, Institute of Life Sciences, Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization EA Pharma Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Mie University Hospital
Address 2-174 Edobashi Tsu Mie
Tel 059-232-1111
Email ytoi0725@clin.medic.mie-u.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
2019 Year 03 Month 15 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
2019 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 15 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2019 Year 03 Month 14 Day
Last modified on
2019 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041242

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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