UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034127 |
|---|---|
| Receipt number | 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 | 2021/09/16 20:09:53 |
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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
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
km1219@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university Graduate School of Medicine
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038890
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
