UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060591 |
|---|---|
| Receipt number | R000069305 |
| Scientific Title | A prospective observational study to clarify the usefulness of bronchial lavage in patients with anti-GPL-core IgA antibody-positive pulmonary nontuberculous mycobacterial disease |
| Date of disclosure of the study information | 2026/02/05 |
| Last modified on | 2026/02/06 13:55:34 |
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Basic information
Public title
A prospective observational study to clarify the usefulness of bronchial lavage in patients with anti-GPL-core IgA antibody-positive pulmonary nontuberculous mycobacterial disease
Acronym
A prospective observational study to clarify the usefulness of bronchial lavage in patients with anti-GPL-core IgA antibody-positive pulmonary nontuberculous mycobacterial disease
Scientific Title
A prospective observational study to clarify the usefulness of bronchial lavage in patients with anti-GPL-core IgA antibody-positive pulmonary nontuberculous mycobacterial disease
Scientific Title:Acronym
A prospective observational study to clarify the usefulness of bronchial lavage in patients with anti-GPL-core IgA antibody-positive pulmonary nontuberculous mycobacterial disease
Region
| Japan |
Condition
Condition
Pulmonary infection due to non-tuberculous mycobacterium
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the usefulness of bronchial lavage (BL) during bronchoscopy in diagnosing pulmonary nontuberculous mycobacterial disease in patients with positive anti-GPL-core IgA antibodies (GPL core IgA antibodies: MAC antibodies 0.7 U/mL or higher).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic rate of BL for NTM: Percentage of BL culture positive cases in MAC antibody (qualitative acid-fast bacillary antibody) positive cases (GPL core IgA antibody: MAC antibody 0.7 U/mL or higher)
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(a) Patients eligible for bronchoscopy
(b) Patients undergoing elective bronchoscopy
(c) Patients with a performance status of 2 or less
(d) Patients with written consent
(e) Patients aged 20 years or older (regardless of gender)
(f) Patients with positive MAC antibodies (qualitative mycobacterial antibodies) (GPL core IgA antibody: MAC antibody 0.7 U/mL or higher)
Key exclusion criteria
(a) Patients with contraindications for bronchoscopy
(b) Patients with mental conditions that make it difficult to participate in a clinical trial
(C) Patients who are otherwise deemed inappropriate for enrollment in this study by a physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | DAISUKE |
| Middle name | |
| Last name | MINAMI |
Organization
Himeji Saint Mary's Hospital
Division name
Department of Respiratory Medicine
Zip code
670-0801
Address
650, Nibuno, Himeji city, Hyogo prefecture
TEL
0792655111
d-minami@bj8.so-net.ne.jp
Public contact
Name of contact person
| 1st name | DAISUKE |
| Middle name | |
| Last name | MINAMI |
Organization
Himeji Saint Mary's Hospital
Division name
Department of Respiratory Medicine
Zip code
670-0801
Address
650, Nibuno, Himeji city, Hyogo prefecture
TEL
0792655111
Homepage URL
d-minami@bj8.so-net.ne.jp
Sponsor or person
Institute
Himeji Saint Mary's Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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 prefecture
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
| 2026 | Year | 02 | Month | 05 | 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
| 2026 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After approval by the Institutional Review Board, patients scheduled for bronchoscopy for the diagnosis of NTM between the date of study implementation and the enrollment period on February 28, 2027 will be included. The target number of cases is 50. This is an observational study, and all patients undergoing bronchoscopy for the diagnosis of NTM within the study period will be included. Himeji Maria Hospital, where this study will be conducted, performs approximately 30 bronchoscopies for the diagnosis of NTM annually. Assuming a consent rate of approximately 80%, approximately 24 patients from Himeji Maria Hospital are expected to participate in the study during the study period. Including patients from Himeji Medical Center, Himeji Red Cross Hospital, Kawasaki Medical School (General Internal Medicine 4), Fukuyama Medical Center, Fukuyama City Hospital, Kurashiki Central Hospital, Hiroshima Prefectural Hospital, Yamaguchi University Hospital, Iwakuni Medical Center, Shimane University Hospital, Tottori University Hospital, and Okayama Medical Center, approximately 50 patients are expected to participate during the study period.
Management information
Registered date
| 2026 | Year | 02 | Month | 05 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069305
