UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036203 |
|---|---|
| Receipt number | 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 | 2021/07/20 08:39:54 |
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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
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
ytoi0725@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Division of Reparative Medicine, Institute of Life Sciences, Mie University Graduate School of Medicine
Institute
Department
Personal name
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
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 02 | Day |
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
| 2021 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041242
