UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010231 |
|---|---|
| Receipt number | R000011953 |
| Scientific Title | Multiinstitutional prospective study on idiopathic interstitial pneumonias with features similar to collagen vascular diseases |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2022/10/05 15:53:31 |
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Basic information
Public title
Multiinstitutional prospective study on idiopathic interstitial pneumonias with features similar to collagen vascular diseases
Acronym
IIPs with features similar to CVD
Scientific Title
Multiinstitutional prospective study on idiopathic interstitial pneumonias with features similar to collagen vascular diseases
Scientific Title:Acronym
IIPs with features similar to CVD
Region
| Japan |
Condition
Condition
Idiopathic interstitial pneumonias
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical course and prognosis in idiopathic interstitial pneumonias with features similar to collagen vascular diseases
Basic objectives2
Others
Basic objectives -Others
To evaluate the incidence of idiopathic interstitial pneumonias with features similar to collagen vascular diseases
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival rate
Key secondary outcomes
Change in Forced Vital Capacity, Change of lung opacities on High Resolution Computed Tomography
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with idiopathic interstitial pneumonias
Key exclusion criteria
Patients who meet the criteria for any collagen vascular diseases
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashiku, Hamamatsu, Japan
TEL
81534352263
norieno@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Enomoto |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashiku, Hamamatsu, Japan
TEL
81534352263
Homepage URL
norieno@hama-med.ac.jp
Sponsor or person
Institute
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor, and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medcine
Address
1-20-1 Handayama, Higashiku, Hamamatsu, Japan
Tel
053-435-2263
norieno@hama-med.ac.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
| 2013 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.hama-med.ac.jp/uni-e/
Publication of results
Published
Result
URL related to results and publications
https://thorax.bmj.com/content/77/2/143.long
Number of participants that the trial has enrolled
376
Results
In this multicenter cohort study, 376 patients with IIP prospectively enrolled, and 70 patients (18.6%) met the IPAF criteria. During a median observation period of 35 months, patients with IPAF more frequently developed systemic autoimmune diseases and had less frequent acute exacerbation of IIPs than patients with non-IPAF. IPAF diagnosis was significantly associated with better survival and was an independent positive prognostic factor in total and patients with non-IPF.
Results date posted
| 2022 | Year | 10 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with idiopathic interstitial pneumonia
Participant flow
Multicenter prospective cohort study
Adverse events
none
Outcome measures
Survival in patients with IPAF
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2013 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Incidence, response rate to treatments, and prognosis will be observed prospectively in patients with idiopathic interstitial pneumonias with features similar to collagen vascular diseases. Patients with idiopathic interstitial pneumonias will be enrolled consecutively.
Management information
Registered date
| 2013 | Year | 03 | Month | 13 | Day |
Last modified on
| 2022 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011953
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
