UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034127
Receipt No. R000038890
Scientific Title Observational study on health condition of patients with ulcerative colitis
Date of disclosure of the study information 2018/09/13
Last modified on 2019/03/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Yuichi
Middle name
Last name Kida
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 ykida@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
2019 Year 03 Month 18 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.