UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039014 |
|---|---|
| Receipt number | 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 09:39:41 |
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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
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
uwamino@a7.keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044486
