UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026907 |
|---|---|
| Receipt number | R000030764 |
| Scientific Title | Clinical survey on Aspergillus species in patients with chronic obstructive disease |
| Date of disclosure of the study information | 2017/04/09 |
| Last modified on | 2017/04/08 20:51:38 |
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Basic information
Public title
Clinical survey on Aspergillus species in patients with chronic obstructive disease
Acronym
Clinical survey of Aspergillus in COPD patient
Scientific Title
Clinical survey on Aspergillus species in patients with chronic obstructive disease
Scientific Title:Acronym
Clinical survey of Aspergillus in COPD patient
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical influence of Aspergillus sp. in patients with COPD.
Basic objectives2
Others
Basic objectives -Others
To survey the clinical influence of Aspergillus sp. in patients with chronic obstructive disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prognosis, sever acuteexacerbation,decline of pulmonary function test according to the Aspergillus related tests
Key secondary outcomes
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
Patients with COPD
Key exclusion criteria
COPD patients without sufficient medical information.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
1-20-1 Handayama, Hamamatsu, Japan
TEL
053-435-2263
ky@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Yoshimura |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
1-20-1 Handayama, Hamamatsu, Japan
TEL
053-435-2263
Homepage URL
ky@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Second Division, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Second Division, Department of Internal 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
静岡県浜松市 聖隷三方原病院
静岡県磐田市 磐田市立総合病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 09 | 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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 04 | Month | 30 | Day |
Other
Other related information
Observational study
Management information
Registered date
| 2017 | Year | 04 | Month | 08 | Day |
Last modified on
| 2017 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030764
