UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017376 |
|---|---|
| Receipt number | R000020162 |
| Scientific Title | Ishinomaki COPD Registry and a Registry-Based Cohort Study |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2021/05/06 18:13:13 |
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Basic information
Public title
Ishinomaki COPD Registry and a Registry-Based Cohort Study
Acronym
I-CORE and Cohort
Scientific Title
Ishinomaki COPD Registry and a Registry-Based Cohort Study
Scientific Title:Acronym
I-CORE and Cohort
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate health outcomes in Japanese patients with COPD according to their clinical characteristics, including comorbidities/pulmonary complications.
Basic objectives2
Others
Basic objectives -Others
A regional COPD registry and a registry-based cohort Study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival
Key secondary outcomes
Pulmonary function, exacerbations
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 with COPD who had their diagnosis confirmed using spirometry. Patients with chronic bronchitis or emphysema without airflow obstruction are also included. Patients with ACOS or CPFE are also included.
Key exclusion criteria
None.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Seiichi |
| Middle name | |
| Last name | Kobayashi |
Organization
Japanese Red Cross Ishinomaki Hospital
Division name
Department of Respiratory Medicine
Zip code
98685222
Address
71 Nishimichishita, Hebita, Ishinomaki, Japan
TEL
0225-21-7220
skoba-thk@umin.ac.jp
Public contact
Name of contact person
| 1st name | Seiichi |
| Middle name | |
| Last name | Kobayashi |
Organization
Japanese Red Cross Ishinomaki Hospital
Division name
Department of Respiratory Medicine
Zip code
9808522
Address
71 Nishimichishita, Hebita, Ishinomaki, Japan
TEL
0225-21-7220
Homepage URL
skoba-thk@umin.ac.jp
Sponsor or person
Institute
Japanese Red Cross Ishinomaki Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ishinomaki COPD Network (ICON)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the Japanese Red Cross Ishinomaki Hospital
Address
71 Nishimichishita, Hebita, Ishinomaki, Miyagi, Japan
Tel
0225-21-7220
i-hosp@ishinomaki.jrc.or.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
石巻赤十字病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | 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
| 2015 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective study using the registory databese. A registory-based prospective observational study.
Management information
Registered date
| 2015 | Year | 05 | Month | 01 | Day |
Last modified on
| 2021 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020162
