UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between endoscopic mucosal healing and histologic inflammation during remission maintenance phase in ulcerative colitis
Title of the study (Brief title)	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	Mimari Kanazawa
Organization	Dokkyo Medical University
Division name	Department of Gastroenterology
Address	880, Kitakobayashi, Mibu, Shimotsuga, Tochigi 321-0293, Japan.
TEL	0282872147
Email	mimari77@dikkyomed.ac.jp

Public contact
Name of contact person	Mimari Kanazawa
Organization	Dokkyo Medical University
Division name	Department of Gastroenterology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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