UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012933 |
|---|---|
| Receipt number | R000015111 |
| Scientific Title | Prospective observational study to evaluate prognostic and predictive value of initial HRCT findings in elderly patients with interstitial pneumonia |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2018/04/17 01:09:14 |
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Basic information
Public title
Prospective observational study to evaluate prognostic and predictive value of initial HRCT findings in elderly patients with interstitial pneumonia
Acronym
Relationship between initial HRCT findings and prognosis of interstitial pneumonia in elderly
Scientific Title
Prospective observational study to evaluate prognostic and predictive value of initial HRCT findings in elderly patients with interstitial pneumonia
Scientific Title:Acronym
Relationship between initial HRCT findings and prognosis of interstitial pneumonia in elderly
Region
| Japan |
Condition
Condition
Interstitial pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the relationship between initial HRCT finding and prognosis in elderly patients with interstitial pneumonia.
Basic objectives2
Others
Basic objectives -Others
Prospective observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of progression free survival (PFS) in each group.
Definition of progression is 10% < decline of %FVC or 15% < decline of DLCO compared with initial pulmonary function test, the introduction of home oxygen therapy, more than 90days hospitalization due to irreversible worsening of respiratory status, or death.
Key secondary outcomes
Secondary outcomes are the changes of Modified Medical Research Council Dyspnea Scale, percutaneous oxygen saturation, partial pressure of oxygen in arterial blood, vital capacity, forced vital capacity, the distance and minimum SPO2 of 6 minutes walk test, KL-6/SP-D, Overall 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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible patients are men and women aged 75 years or older with interstitial pneumonia in initial chest HRCT.
Key exclusion criteria
Patients who have malignant tumor, defined connective tissue disease, occupational and/or environmental exposure that resulted in interstitial pneumonia, or drug induced interstitial pneumonia are excluded from this study. Patient who have already used home oxygen therapy at first visit are also excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyoshi Imaizumi |
Organization
Fujita Health University School of Medicine
Division name
Division of Respiratory Medicine and Clinical Allergy
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho Toyoake, Aichi Japan
TEL
0562-93-9241
jeanluc@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Minezawa |
Organization
Fujita Health University School of Medicine
Division name
Division of Respiratory Medicine and Clinical Allergy
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho Toyoake, Aichi Japan
TEL
0562-93-9241
Homepage URL
minezawa@fujita-hu.ac.jp
Sponsor or person
Institute
Division of Respiratory Medicine and Clinical Allergy,Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Respiratory Medicine and Clinical Allergy,Fujita Health University School of Medicine
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
Address
Tel
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 | 02 | Month | 01 | 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
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To assess the relationship between initial HRCT finding and prognosis in elderly patients with interstitial pneumonia.
Management information
Registered date
| 2014 | Year | 01 | Month | 23 | Day |
Last modified on
| 2018 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015111
| Research Plan | |
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| 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 |
