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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033452
Receipt No. 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

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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
Email 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
Email mimari77@dikkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Department of Gastroenterology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038127

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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