UMIN-CTR Clinical Trial

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