UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of clinical usefulness of detection method for Aspergillus fumigatus using LAMP
Title of the study (Brief title)	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	Akira Watanabe
Organization	Chiba University Hospital
Division name	Division of Infectious Diseases
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	043-222-7171
Email	fewata@faculty.chiba-u.jp

Public contact
Name of contact person	Akira Watanabe
Organization	Chiba University Hospital
Division name	Division of Infectious Diseases
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	043-222-7171
Homepage URL
Email	fewata@faculty.chiba-u.jp

Sponsor
Institute	Division of Infectious Diseases, Chiba University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033802