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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026907
Receipt No. 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

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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
Email 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
Email ky@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Second Division, Department of Internal Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030764

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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