UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028506 |
|---|---|
| Receipt number | R000032408 |
| Scientific Title | Prospective study for investigating the clinical course of Crohn's disease |
| Date of disclosure of the study information | 2017/08/31 |
| Last modified on | 2018/03/08 16:35:34 |
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Basic information
Public title
Prospective study for investigating the clinical course of Crohn's disease
Acronym
Prospective study for investigating the clinical course of Crohn's disease
Scientific Title
Prospective study for investigating the clinical course of Crohn's disease
Scientific Title:Acronym
Prospective study for investigating the clinical course of Crohn's disease
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the recent clinical course of Crohn's disease and factors that affect the surgery, emergency hospitalization, clinical relapse and Quality of life.
Basic objectives2
Others
Basic objectives -Others
Image diagnosis of Crohn's disease and its relationship with clinical features
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative non-operative rate
Cumulative non-emergency hospitalization rate
Key secondary outcomes
Clinical factors on cumulative nonoperative rate,cumulative non-emergency hospitalization 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed as Crohn's disease.
Key exclusion criteria
1.Patient without the ability for self-judgment.
2.Medical doctors decided the patients are inapropriate.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Watanabe |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65 Tsurumai-cho,Showa-ku,Nagoya
TEL
052-744-2172
osa-wata@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Nishikawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65 Tsurumai-cho,Showa-ku,Nagoya
TEL
052-744-2172
Homepage URL
t.nishikawa@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
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
Address
Tel
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
| 2017 | Year | 08 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design:Case series study
Measurements;
General information(age,gender,height,body weight,symptom,disease duration,past history,operation history,medication,family history,physical findings),Treatment,Image findings,Endoscopic findings,Capsule endoscopic findings,Endoscopic treatment,histopathological findings,blood exam(red blood cells, white blood cells, platelets, albumin,total cholesterol,hepatobiliary system enzyme, lactase dehydrogenase,amylase, C-reactive protein, blood urea nitrogen, creatinine, erythrocyte sedimentation rate,blood,concentration of infliximab),CDAI(Crohn's Disease Activity Index),IBDQ(Inflammatory Bowel Disease Questionnaire)
Management information
Registered date
| 2017 | Year | 08 | Month | 02 | Day |
Last modified on
| 2018 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032408
