UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047834 |
|---|---|
| Receipt number | R000054533 |
| Scientific Title | The single-institutional prospective observational study to evaluate the severity of the pulmonary disease using the data of the physical activity. |
| Date of disclosure of the study information | 2022/05/23 |
| Last modified on | 2024/08/09 15:59:20 |
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Basic information
Public title
The single-institutional prospective observational study to evaluate the severity of the pulmonary disease using the data of the physical activity.
Acronym
Prospective observational study of physical activity in patients with pulmonary disease
Scientific Title
The single-institutional prospective observational study to evaluate the severity of the pulmonary disease using the data of the physical activity.
Scientific Title:Acronym
Prospective observational study of physical activity in patients with pulmonary disease
Region
| Japan |
Condition
Condition
COPD, Interstitial pneumonia, lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate physical activity by ePRO in patients with pulmonary disease.
Physical activity will be collected for 2 weeks to investigate the association with mMRC in interstitial pneumonia, GOLD classification in COPD, and ECOG PS in lung cancer at the time of study.
Basic objectives2
Others
Basic objectives -Others
To evaluate the availability of ePRO as a method for measuring physical activity.
6/12/18 months will be observed for chest disease events and death events.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC by ROC analysis for severity based on the pulmonary disease.
Key secondary outcomes
Sensitivity, Specificity, Accuracy rate for each ROC analysis
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
Inclusion criteria
1. Diagnosed with pulmonary disease as below: COPD, interstitial pneumonia, lung cancer.
2. Pulmonary function test, Chest CT is planned.
3. Can use the ePRO device for measuring physical activity.
4. Written informed consent
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Ito |
Organization
Matsusaka Municipal Hospital
Division name
Respiratory Center
Zip code
5150073
Address
1550, Tonomachi, Matsusaka City, Mie, Japan
TEL
0598231515
kentarou_i_0214@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Ito |
Organization
Matsusaka Municipal Hospital
Division name
Respiratory Center
Zip code
5150073
Address
1550, Tonomachi, Matsusaka City, Mie, Japan
TEL
0598231515
Homepage URL
kentarou_i_0214@yahoo.co.jp
Sponsor or person
Institute
Matsusaka Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Matsusaka Municipal Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsusaka Municipal Hospital
Address
1550, Tonomachi, Matsusaka City, Mie, Japan
Tel
0598231515
kentarou_i_0214@yahoo.co.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
| 2022 | Year | 05 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://jamanetwork.com/journals/jamaoncology/fullarticle/2816983
Number of participants that the trial has enrolled
238
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
Main results already published
Date of protocol fixation
| 2021 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Physical activity will be collected for 2 weeks to investigate the association with mMRC in interstitial pneumonia, GOLD classification in COPD, and ECOG PS in lung cancer at the time of study. 6/12/18 months will be observed for chest disease events and death events.
Management information
Registered date
| 2022 | Year | 05 | Month | 23 | Day |
Last modified on
| 2024 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054533
