UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044675 |
|---|---|
| Receipt number | R000051023 |
| Scientific Title | Diagnostic utility of linked color imaging in the evaluation of disease activity and prediction of relapse in ulcerative colitis |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2021/06/27 17:35:39 |
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Basic information
Public title
Diagnostic utility of linked color imaging in the evaluation of disease activity and prediction of relapse in ulcerative colitis
Acronym
Diagnostic utility of linked color imaging in the evaluation of disease activity and prediction of relapse in ulcerative colitis
Scientific Title
Diagnostic utility of linked color imaging in the evaluation of disease activity and prediction of relapse in ulcerative colitis
Scientific Title:Acronym
Diagnostic utility of linked color imaging in the evaluation of disease activity and prediction of relapse in ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Linked-color imaging (LCI) is a new endoscopy system that enhances the color differences of the gastrointestinal mucosa. The aim of this study is to investigate the efficacy of LCI in the evaluation of intestinal activity and prediction of relapse in UC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
correlation between disease activity by LCI and time to repalpse
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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
age: from 16 to 80
The patients diagnosed as UC and treated at Nippon Medical School Tamanagayama Hospital and who underwent colonoscopy.
Key exclusion criteria
Patients with severe ulcerative colitis, poor general condition, patients without informed consent, pregnant patients were excluded from the present study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shu |
| Middle name | |
| Last name | Tanaka |
Organization
Nippom Medical School Tamanagayama Hospital
Division name
Gastroenterology
Zip code
206-8512
Address
1-7-1, Nagayama, Tama-shi, Tokyo
TEL
042-371-2111
tanashu55@hotmail.com
Public contact
Name of contact person
| 1st name | Shu |
| Middle name | |
| Last name | Tanaka |
Organization
Nippom Medical School Tamanagayama Hospital
Division name
Gastroenterology
Zip code
206-8512
Address
1-7-1, Nagayama, Tama-shi, Tokyo
TEL
09080148637
Homepage URL
tanashu55@hotmail.com
Sponsor or person
Institute
Nippom Medical School Tamanagayama Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippom Medical School Tamanagayama Hospital
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
Nippon Medical School Tamanagayama Hospital Ethics Committee
Address
1-7-1, Nagayama, Tama-shi, Tokyo
Tel
09080148637
tanashu55@hotmail.com
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
| 2021 | Year | 07 | 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
| 2021 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. patients data
2. disease history
3. clinical synptom
4. laboratory data
5. colonoscopy findings
6. histrogical findings
7. adverse events
Management information
Registered date
| 2021 | Year | 06 | Month | 27 | Day |
Last modified on
| 2021 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051023
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
