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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039014
Receipt No. R000044486
Scientific Title Research for biomarkers in airway specimens in pulmonary mycobacterial infections
Date of disclosure of the study information 2020/01/01
Last modified on 2019/12/27

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Basic information
Public title Research for biomarkers in airway specimens in pulmonary mycobacterial infections
Acronym Respiratory biomarker study in mycobacterial infections
Scientific Title Research for biomarkers in airway specimens in pulmonary mycobacterial infections
Scientific Title:Acronym Respiratory biomarker study in mycobacterial infections
Region
Japan

Condition
Condition Mycobacterial infection
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To identify biomarkers in the respiratory tract that can be used as indicators of diagnosis, treatment responsiveness, severity or prognosis of mycobacterial infections and verify their clinical usefulness
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Concentration of biomarkers in airway samples
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with Mycobacterial infection, bronchiectasis or chronic respiratory infections.
Key exclusion criteria Pediatric patient
Target sample size 700

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Hasegawa
Organization Keio University
Division name Department of Infectious Diseases, School of Medicine
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL +81-3-3353-1211
Email n-hasegawa@z8.keio.jp

Public contact
Name of contact person
1st name Yoshifumi
Middle name
Last name Uwamino
Organization Keio University
Division name Department of Laboratory Medicine, School of Medicine
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL +81-3-3353-1211
Homepage URL
Email uwamino@a7.keio.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Board of ethics, Keio University School of Medicine
Address 35 Shinanomachi, Shinjuku, Tokyo
Tel +81-3-3353-1211
Email not appricable

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
2020 Year 01 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 Enrolling by invitation
Date of protocol fixation
2019 Year 11 Month 05 Day
Date of IRB
2019 Year 12 Month 24 Day
Anticipated trial start date
2020 Year 01 Month 01 Day
Last follow-up date
2025 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Biomarkers such as bacterial load, protein, amino acid, lipid, carbon hydrates, micro RNA, microbiota and physical properties of respiratory samples from patients will be measured and evaluate correlation with serum or plasma biomarkers, imaging data, microbiological data, genetic findings obtained from clinical practices and other clinical studies.

Management information
Registered date
2019 Year 12 Month 27 Day
Last modified on
2019 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044486

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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