UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033452 |
|---|---|
| Receipt number | R000038127 |
| Scientific Title | Relationship between endoscopic mucosal healing and histologic inflammation during remission maintenance phase in ulcerative colitis |
| Date of disclosure of the study information | 2018/07/19 |
| Last modified on | 2018/07/19 21:01:02 |
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Basic information
Public title
Relationship between endoscopic mucosal healing and histologic inflammation during remission maintenance phase in ulcerative colitis
Acronym
Relationship between endoscopic mucosal healing and histologic inflammation during remission maintenance phase in ulcerative colitis
Scientific Title
Relationship between endoscopic mucosal healing and histologic inflammation during remission maintenance phase in ulcerative colitis
Scientific Title:Acronym
Relationship between endoscopic mucosal healing and histologic inflammation during remission maintenance phase in ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is retrospectively compared the severity of histological inflammation with endoscopic findings in UC patients with mucosal healing (MH) in the remission maintenance phase, and investigated whether histological healing could be a predictor of sustained remission.
Basic objectives2
Others
Basic objectives -Others
Clinical utility
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint of this study was to examine whether histological healing could be a predictor of sustained remission in ulcerative colitis patients with mucosal healing.
Key secondary outcomes
The second endpoint was to investigate the risk factors for relapse (age, sex, affected area, disease duration, and smoking rate).
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
| 12 | years-old | <= |
Age-upper limit
| 86 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who had remained in clinical remission with only 5-aminosalicylic acid for at least 1 year without dose modification, who had been found to have mucosal healing by colonoscopy, and who had undergone a biopsy.
Key exclusion criteria
A case which the compliance rate is less than 80%.
A case using biologics agents.
A case using immunomodulators.
Target sample size
166
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mimari Kanazawa |
Organization
Dokkyo Medical University
Division name
Department of Gastroenterology
Zip code
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan.
TEL
0282872147
mimari77@dikkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mimari Kanazawa |
Organization
Dokkyo Medical University
Division name
Department of Gastroenterology
Zip code
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan.
TEL
0282872147
Homepage URL
mimari77@dikkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Red Cross Ashikaga Hospital
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
| 2018 | Year | 07 | Month | 19 | 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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | 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
None.
Management information
Registered date
| 2018 | Year | 07 | Month | 19 | Day |
Last modified on
| 2018 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038127
