UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015370 |
|---|---|
| Receipt number | R000017492 |
| Scientific Title | A cohort study of idiopathic interstitial pneumonia in Shizuoka. |
| Date of disclosure of the study information | 2014/10/10 |
| Last modified on | 2024/10/17 14:15:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A cohort study of idiopathic interstitial pneumonia in Shizuoka.
Acronym
IIPs Shizuoka cohort study
Scientific Title
A cohort study of idiopathic interstitial pneumonia in Shizuoka.
Scientific Title:Acronym
IIPs Shizuoka cohort study
Region
| Japan |
Condition
Condition
Idiopathic interstitial pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal subtypes of idiopathic interstitial pneumonia in Shizuoka prefecture.
Basic objectives2
Others
Basic objectives -Others
To evaluate HRCT findings, lung pathological findings, and autoantibodies/cytokines in patients with idiopathic interstitial pneumonia having rheumatologic flavor.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in forced vital capacity
Key secondary outcomes
Changes in diffusion lung capacity for carbon monoxide (DLCO), distance and minimum-SpO2 in 6 minute walk test, PaO2 at rest, HRCT findings, and survival.
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 diagnosed as idiopathic interstitial pneumonia
Patients aged 15-year old or more
Patients who agree that they participate in this study
Key exclusion criteria
Patients with pneumoconiosis, drug-induced pneumonia, and other lung disorders
Patients who meet the diagnostic criteria of any connective tissue disorders
Patients aged less than 15-year old
Patients who disagree that they participate in this study
Target sample size
200
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
Handayama1-20-1, Chuouku, Hamamatsu, Shizuoka
TEL
+81-53-435-2263
suda@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
Handayama 1-20-1, Chuouku, Hamamatsu, Shizuoka
TEL
+81-53-435-2263
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
None
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
Hamamatsu University School of Medicine
Address
Handayama 1-20-1, Chuouku, Hamamatsu, Shizuoka
Tel
+81-53-435-2263
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
| 2014 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
222
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with idiopathic interstitial pneumonia will be enrolled consecutively, and will be followed prospectively.
Mainly, patients with idiopathic interstitial pneumonia having rheumatologic flavor will be investigated. Demographic data, HRCT, lung pathological specimens, serum of all patients will be evaluated.
Management information
Registered date
| 2014 | Year | 10 | Month | 08 | Day |
Last modified on
| 2024 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017492
