UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053998 |
|---|---|
| Receipt number | R000045696 |
| Scientific Title | Evaluation of treatment strategies, treatment results, prognosis, and safety in respiratory disease medical care. |
| Date of disclosure of the study information | 2024/03/28 |
| Last modified on | 2024/05/06 23:50:00 |
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Basic information
Public title
Evaluation of treatment strategies, treatment results, prognosis, and safety in respiratory disease medical care.
Acronym
Evaluation of treatment strategies, treatment results, prognosis, and safety in respiratory disease medical care.
Scientific Title
Evaluation of treatment strategies, treatment results, prognosis, and safety in respiratory disease medical care.
Scientific Title:Acronym
Evaluation of treatment strategies, treatment results, prognosis, and safety in respiratory disease medical care.
Region
| Japan |
Condition
Condition
Respiratory disease without thoracic cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyze the medical treatment record of each respiratory disease to evaluate the effect on the disease state associated with the treatment.
Basic objectives2
Others
Basic objectives -Others
Analyze the medical treatment record of each respiratory disease to verify the respiratory disease state evaluation method for each disease or each treatment, and the effect on safety and prognosis associated with the treatment.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comprehensive study of the effects of respiratory treatment on respiratory disease
Key secondary outcomes
Creating optimal medical procedures in respiratory medical treatment.
Examination of safety and prognosis for each treatment in respiratory disease patients.
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
1) Patients having COPD or IPF aged 20 years and older (males and females)
2) Patients with respiratory disease attended at this hospital, Nippon medical school Respiratory Care Clinic, or Department of Respiratory Medicine, Nippon Medical School, Chiba Hokusoh Hospital.
3) Inpatients and outpatients
Key exclusion criteria
1)patients with thoracic cancer.
2) Patients who show the rejection to participate in this study.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Tanaka |
Organization
Nippon Medical School
Division name
Department of Pulmonary Medicine and Oncology, Graduate School of Medicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
+81-3-58146266
yosuke-t@nms.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Tanaka |
Organization
Nippon Medical School
Division name
Department of Pulmonary Medicine and Oncology, Graduate School of Medicine
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
+81-3-58146266
Homepage URL
yosuke-t@nms.ac.jp
Sponsor or person
Institute
Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School
Institute
Department
Personal name
Yosuke Tanaka
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
N/A
Other related organizations
Co-sponsor
Department of Respiratory Medicine, Nippon Medical School, Chiba Hokusoh Hospital
Nippon Medical School, Respiratory Care Clinic
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
the Ethics Committee of Nippon Medical School
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
Tel
+81-3-58146266
nms@esct.bvits.com
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
日本医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 28 | 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
| 2020 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2035 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2035 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2035 | Year | 04 | Month | 30 | Day |
Other
Other related information
nonintevention
observational
Management information
Registered date
| 2024 | Year | 03 | Month | 28 | Day |
Last modified on
| 2024 | 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=R000045696
