UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049420 |
|---|---|
| Receipt number | R000056271 |
| Scientific Title | Unreported symptomatic exacerbation and progressive pulmonary fibrosis in patients with interstitial lung disease: prospective observational study using a disease management system (YaDoc) |
| Date of disclosure of the study information | 2022/11/04 |
| Last modified on | 2023/05/10 23:09:00 |
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Basic information
Public title
Unreported symptomatic exacerbation and progressive pulmonary fibrosis in patients with interstitial lung disease: prospective observational study using a disease management system (YaDoc)
Acronym
uSE and PPF in patients with ILD
Scientific Title
Unreported symptomatic exacerbation and progressive pulmonary fibrosis in patients with interstitial lung disease: prospective observational study using a disease management system (YaDoc)
Scientific Title:Acronym
uSE and PPF in patients with ILD
Region
| Japan |
Condition
Condition
Interstitial Lung Disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the prevalence of PPF and association PPF with uSE in patients with ILD who use YaDoc.
Basic objectives2
Others
Basic objectives -Others
To clarify the association PPF with uSE in patients with ILD.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluate the association PPF with uSE
Key secondary outcomes
Prevalence of uSE, action plan adherence, reasons and frequency of unscheduled visits and comparison to uSE, analysis of early predictors of acute exacerbations of ILD, trends in patient-reported outcomes, medication adherence rates, YaDoc adherence, YaDoc safety
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ILD
Patients using or new to YaDoc
Key exclusion criteria
Cases in which the patient refuses to participate in the study with regard to the content of the study
Patients who have difficulty understanding the action plan
Patients deemed inappropriate by the attending physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kondoh |
Organization
Tosei General Hospital
Division name
Department of Respiratory Medicine and Allergy
Zip code
489-8642
Address
160 Nishioiwake Seto Aichi Japan
TEL
0561-82-5101
konyasu2003@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Reoto |
| Middle name | |
| Last name | Takei |
Organization
Tosei General Hospital
Division name
Department of Respiratory Medicine and Allergy
Zip code
489-8642
Address
160 Nishioiwake Seto Aichi Japan
TEL
0561-82-5101
Homepage URL
rtakei415@gmail.com
Sponsor or person
Institute
Tosei General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tosei General Hospital IRB
Address
160 Nishioiwake Seto Aichi Japan
Tel
0561-82-5101
ychikenn@tosei.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 04 | 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
| 2022 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical findings at registration
Prospective collection of clinical findings, uSE and PRO
Clinical findings at unscheduled visits
Management information
Registered date
| 2022 | Year | 11 | Month | 03 | Day |
Last modified on
| 2023 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056271
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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