UMIN-CTR Clinical Trial

Basic information
Public title	Observational study on health condition of patients with ulcerative colitis
Acronym	Observational study on health condition of patients with ulcerative colitis
Scientific Title	Observational study on health condition of patients with ulcerative colitis
Scientific Title:Acronym	Observational study on health condition of patients with ulcerative colitis
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Observe the clinical course of patients with ulcerative colitis and investigate the factors involved in the occurrence of events such as hospitalization and surgery.
Basic objectives2	Others
Basic objectives -Others	Observe the clinical course of patients with ulcerative colitis and investigate the factors involved in the occurrence of events such as hospitalization and surgery.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cumulative non-emergency hospitalization rate
Key secondary outcomes	Cumulative non-operation rate Comparison of disease activity and endoscopic activity in groups with and without events (emergency hospitalization, surgery) Comparison of the expression of inflammatory cytokines in the group with and without events Comparison of lymphocyte subsets of events with and without events Comparison of microbiota of the group with and without event Comparison of drug concentrations and anti-drug antibody with and without events

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who diagnosed with ulcerative colitis. Patients who have received adequate information regarding this study and submitted written consent forms to this study.
Key exclusion criteria	Patients who have a history of psychosomatic disorders. Patients judged as inappropriate for the study because of their conditions.
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Masanao Middle name Last name Nakamura
Organization	Nagoya university hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	4668650
Address	65,Tsurumai-cho,Showa-ku,Nagoya city,Aichi prefecture
TEL	052-741-2172
Email	makamura@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Kentaro Middle name Last name Murate
Organization	Nagoya university Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	4668650
Address	65,Tsurumai-cho,Showa-ku,Nagoya city,Aichi prefecture
TEL	052-741-2172
Homepage URL
Email	km1219@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya university Graduate School of Medicine Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Nagoya university
Address	65,Tsurumai-cho,Showa-ku,Nagoya city,Aichi prefecture
Tel	052-744-2973
Email	ethics@med.nagoya-u.ac.jp

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 09 Month 13 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	Enrolling by invitation
Date of protocol fixation	2018 Year 09 Month 13 Day
Date of IRB	2019 Year 01 Month 07 Day
Anticipated trial start date	2019 Year 01 Month 07 Day
Last follow-up date	2022 Year 03 Month 31 Day
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 09 Month 13 Day
Last modified on	2021 Year 09 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038890