UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029587 |
|---|---|
| Receipt number | R000033802 |
| Scientific Title | Investigation of clinical usefulness of detection method for Aspergillus fumigatus using LAMP |
| Date of disclosure of the study information | 2017/10/17 |
| Last modified on | 2018/04/18 16:24:24 |
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Basic information
Public title
Investigation of clinical usefulness of detection method for Aspergillus fumigatus using LAMP
Acronym
Study of LAMP Aspergillus detection method
Scientific Title
Investigation of clinical usefulness of detection method for Aspergillus fumigatus using LAMP
Scientific Title:Acronym
Study of LAMP Aspergillus detection method
Region
| Japan |
Condition
Condition
aspergillosis
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate utility of a developing detection method for Aspergillus fumigatus using loop-mediated isothermal amplification (LAMP) test, performance test using clinical samples will be conducted.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Consistency between the result of LAMP test and the one of each ready-made examination such as serum beta-D-glucan test, serum Aspergillus antigen test, serum Aspergillus antibody test or culture of clinical samples
Key secondary outcomes
Consistency between the result of LAMP test and clinical diagnosis made by attending physician
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients suspected as aspergillosis
Key exclusion criteria
Patients who do not be comply with this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Watanabe |
Organization
Chiba University Hospital
Division name
Division of Infectious Diseases
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-222-7171
fewata@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Watanabe |
Organization
Chiba University Hospital
Division name
Division of Infectious Diseases
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-222-7171
Homepage URL
fewata@faculty.chiba-u.jp
Sponsor or person
Institute
Division of Infectious Diseases, Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Eiken Chemical Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 17 | 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
| 2017 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
completed
Management information
Registered date
| 2017 | Year | 10 | Month | 17 | Day |
Last modified on
| 2018 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033802
