UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051177 |
|---|---|
| Receipt number | R000058345 |
| Scientific Title | Diagnosis of pulmonary nontuberculous mycobacterial infection using bronchoalveolar lavage fluid: A prospective study |
| Date of disclosure of the study information | 2023/05/26 |
| Last modified on | 2023/05/26 17:03:20 |
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Basic information
Public title
Diagnosis of pulmonary nontuberculous mycobacterial infection using bronchoalveolar lavage fluid: A prospective study
Acronym
Diagnosis of pulmonary nontuberculous mycobacterial infection using bronchoalveolar lavage fluid: A prospective study
Scientific Title
Diagnosis of pulmonary nontuberculous mycobacterial infection using bronchoalveolar lavage fluid: A prospective study
Scientific Title:Acronym
Diagnosis of pulmonary nontuberculous mycobacterial infection using bronchoalveolar lavage fluid: A prospective study
Region
| Japan |
Condition
Condition
Pulmonary nontuberculous mycobacterial infection
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study demonstrates the usefulness of bronchoalveolar lavage (BAL) during bronchoscopy in the diagnosis of pulmonary nontuberculous mycobacterial disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary objective was to assess the diagnostic yield of BAL for NTM.
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
(a) Indications for bronchoscopy
(b) Elective bronchoscopy
(c) Patients with a general condition with a performance status of 2 or less
(d) Patients with written informed consent
(e) Cases aged 20 years or older (regardless of gender)
(f) MAC antibody (acid-fast bacteria antibody qualitative) positive case
Key exclusion criteria
(a) Cases contraindicated for bronchoscopy
(b) Patients with a mental condition that makes it difficult to participate in clinical trials
(C) Other cases judged by a doctor to be inappropriate for enrollment in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Minami |
Organization
Hosoya hospital
Division name
Department of Respiratory medicine
Zip code
715-0014
Address
102 Nanokaichicho Ibara city
TEL
09064054337
d-minami@bj8.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Minami |
Organization
Hosoya hospital
Division name
Department of Respiratory medicine
Zip code
715-0014
Address
102 Nanokaichicho Ibara city
TEL
09064054337
Homepage URL
d-minami@bj8.so-net.ne.jp
Sponsor or person
Institute
Hosoya hospital
Institute
Department
Personal name
Funding Source
Organization
others
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Himeji Saint Mary's Hospital
Address
650 Nibuno, Himeji city, hyogo
Tel
0792655111
d-minami@bj8.so-net.ne.jp
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
| 2023 | Year | 05 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation study
Management information
Registered date
| 2023 | Year | 05 | Month | 26 | Day |
Last modified on
| 2023 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058345
