UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021266 |
|---|---|
| Receipt number | R000024521 |
| Scientific Title | Registry of chronic respiratory diseases |
| Date of disclosure of the study information | 2016/03/07 |
| Last modified on | 2016/03/22 16:16:02 |
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Basic information
Public title
Registry of chronic respiratory diseases
Acronym
Registry of chronic respiratory diseases
Scientific Title
Registry of chronic respiratory diseases
Scientific Title:Acronym
Registry of chronic respiratory diseases
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease
Bronchial asthma
Interstitial pneumonia
Chronic respiratory infectious diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the annual changes of symptoms, conditions, and pathophysiology of these chronic respiratory diseases, and to elucidate medical problems and difficulties in treating these patients.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Symptoms, Physical examination, X-ray and/or CT scan, Pulmonary function tests, cardiac function, blood test, etc.
Key secondary outcomes
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
Our patients with chronic obstructive disease, bronchial asthma, interstitial pneumonia or chronic respiratory infectious diseases.
Key exclusion criteria
Patients who refuse the inclusion of this study.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masamichi Mineshita |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory diseases
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-City, Kanagawa, Japan
TEL
044-977-8111
m-mine@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masamichi Mineshita |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory diseases
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-City, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
m-mine@marianna-u.ac.jp
Sponsor or person
Institute
Division of Respiratory diseases, St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Respiratory diseases, St. Marianna University 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
| 2016 | Year | 03 | Month | 07 | 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
| 2016 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | 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
1. Design: Cohort study
2. Eligible patients: Patients who visit our department from 7th Mar 2016 to 31th Dec 2020, satisfy inclusion criteria, and agree for recruitment of this study.
3. Evaluation: Xp and CT findings, Pulmonary function tests, assessments of QOL, Blood tests, etc.
Management information
Registered date
| 2016 | Year | 03 | Month | 01 | Day |
Last modified on
| 2016 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024521
