UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046101 |
|---|---|
| Receipt number | R000052611 |
| Scientific Title | Prediction of clinical relapse by NBI-CAD in patients with ulcerative colitis. |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2022/01/27 12:00:41 |
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Basic information
Public title
Prediction of clinical relapse by NBI-CAD in patients with ulcerative colitis.
Acronym
UC relapse prediction by NBI-CAD
Scientific Title
Prediction of clinical relapse by NBI-CAD in patients with ulcerative colitis.
Scientific Title:Acronym
UC relapse prediction by NBI-CAD
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
NBI-CAD evaluates its usefulness in predicting relapse of ulcerative colitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
UC-CAD clinical relapse rate by diagnosis(12 month).
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a definite diagnosis of ulcerative colitis in advance
Patients undergoing lower gastrointestinal endoscopy due to clinical need
Clinical remission
Endoscopic remission
Patients who have not used prednisolone within 6 months
Patients with no history of radiation therapy for the abdomen or pelvis
Key exclusion criteria
Patients who have been asked to refuse to participate in this study
Patients who could not be followed up at the end of the study or until relapse
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuharu |
| Middle name | |
| Last name | Maeda |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
2248503
Address
35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
TEL
09097786308
yasuharumaeda610@hotmail.com
Public contact
Name of contact person
| 1st name | Yasuharu |
| Middle name | |
| Last name | Maeda |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
2248503
Address
35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
TEL
09097786308
Homepage URL
yasuharumaeda610@hotmail.com
Sponsor or person
Institute
Digestive Disease Center,Showa University Northern Yokohama HospitalDigestive Disease Center,Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Northern Yokohama Hospital
Address
35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
Tel
0459497567
yasuharumaeda610@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 | 12 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the clinical relapse rate by diagnosis of UC-CAD
Management information
Registered date
| 2021 | Year | 11 | Month | 17 | Day |
Last modified on
| 2022 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052611
