UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014731 |
|---|---|
| Receipt number | R000017126 |
| Scientific Title | Predictive factor of relapse following clinical remission in ulcerative colitis patients. |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2014/07/31 21:49:51 |
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Basic information
Public title
Predictive factor of relapse following clinical remission in ulcerative colitis patients.
Acronym
Predictive factor of relapse following clinical remission in ulcerative colitis patients.
Scientific Title
Predictive factor of relapse following clinical remission in ulcerative colitis patients.
Scientific Title:Acronym
Predictive factor of relapse following clinical remission in ulcerative colitis patients.
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find out the predictive factors of relapse in ulcerative colitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Predictive factors of relapse.
(endoscopic findings, stool calprotectin and so on)
Key secondary outcomes
Base
Study type
Interventional
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
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ulcerative colitis who are maintaining clinical remission more than 2 months.
Colonoscopic evaluation is available.
Patients with informed consent.
Key exclusion criteria
Patients with serious complications.
Patients with colectomy.
Cases considered inadequate by investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiro Kodani |
Organization
Juntendo University, Faculty of Medicine
Division name
Gastroenterology
Zip code
Address
2-1-1, Hongo, Bunkyoku, Tokyo, Japan
TEL
03-5802-1060
tkodani@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Kodani |
Organization
Juntendo University, Faculty of Medicine
Division name
Gastroenterology
Zip code
Address
2-1-1, Hongo, Bunkyoku, Tokyo, Japan
TEL
03-5802-1060
Homepage URL
tkodani@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University, Faculty of Medicine
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 | 08 | 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
| 2014 | Year | 07 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 31 | Day |
Last modified on
| 2014 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017126
