UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013603 |
|---|---|
| Receipt number | R000015892 |
| Scientific Title | Evaluation of activity and prediction of relapse by endoscopic vascular scoring in patients with ulcerative colitis |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2019/03/24 15:51:54 |
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Basic information
Public title
Evaluation of activity and prediction of relapse by endoscopic vascular scoring in patients with ulcerative colitis
Acronym
vascular scoring in ulcerative colitis
Scientific Title
Evaluation of activity and prediction of relapse by endoscopic vascular scoring in patients with ulcerative colitis
Scientific Title:Acronym
vascular scoring in ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation the ulitiliy of vascular scoring compring with UCEIS, Baron score and Mayo score
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation with vascular scoring and stool calprotectin concentration
Correlation with vascular scoring and relapse rate in one year
Key secondary outcomes
Correlation with vascular scoring and stool hemoglobin concentration
Correlation with Baron scores and stool hemoglobin or calprotectin concentration
Correlation with UCEIS and stool hemoglobin or calprotectin concentration
Correlation with mayo score and stool hemoglobin or calprotectin concentration
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
evaluation of vascular scoring by colonoscopy
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
| 15 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who will be able to be examined by colonoscopy
Patients who has informed consent
Key exclusion criteria
Patients who will not be able to be examined by colonoscopy
Patient in pregnant and lactate state
Patients who has not informed consent
Patients who has or has been treated malignancy
Patients with colectomy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Kato |
Organization
Saitama Medical Center
Division name
Gastroenterology and Hepatology
Zip code
Address
1981, Kamoda, Kawagoe City, Japan
TEL
049-228-3564
skato@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Kato |
Organization
Saitama Medical Center
Division name
Gastroenterology and hepatology
Zip code
Address
1981, Kamoda, Kawagoe City, Japan
TEL
049-2228-3564
Homepage URL
skato@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 05 | 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
176
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
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 02 | Day |
Last modified on
| 2019 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015892
