UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043426 |
|---|---|
| Receipt number | R000049473 |
| Scientific Title | An observational study on host immunity in patients with refractory Mycobacterium avium complex pulmonary disease: a multicenter observational study |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2022/03/31 21:19:17 |
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Basic information
Public title
An observational study on host immunity in patients with refractory Mycobacterium avium complex pulmonary disease
Acronym
An observational study on host immunity in patients with refractory MAC-PD
Scientific Title
An observational study on host immunity in patients with refractory Mycobacterium avium complex pulmonary disease: a multicenter observational study
Scientific Title:Acronym
An observational study on host immunity in patients with refractory MAC-PD
Region
| Japan |
Condition
Condition
Mycobacterium avium complex pulmonary disease
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
-To determine the host immune characteristics in patients with refractory MAC-PD.
Basic objectives2
Others
Basic objectives -Others
-To make recommendations that will lead to the establishment of novel treatment strategies for refractory MAC-PD.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Clinical outcome
Treatment failure of MAC-PD under the standard treatment.
2) Immunological outcome
Host immune characteristics in treatment failure of MAC-PD under standard treatment.
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
1. Patients with MAC-PD
Patients who have been on multidrug therapy for MAC-PD for at least 12 months and meet the following criteria.
-Age: 20 and older
-Written consent has been obtained.
The diagnostic definition of MAC-PD should meet both of the following criteria 1) and 2).
1) Clinical criteria (Both required)
-Patients with respiratory or systemic symptoms.
-Nodular or cavitary opacities on chest radiograph, or a computed tomography scan that shows bronchiectasis with multiple small nodules.
2) Microbiologic criteria (One of the following is met)
-Positive culture results from at least two separate expectorated sputum samples.
-Positive culture results from at least one bronchial wash or lavage.
-Transbronchial or other lung biopsy with mycobacterial histologic features and one or more positive culture results from sputum, bronchial washing, or lung biopsy
In this study, it is assumed that patients are still on multidrug therapy at the time of study registration, but patients who are discontinued after 12 months of therapy due to difficulty in controlling the disease of MAC-PD can be enrolled.
2. Healthy subjects
Healthy people who meet the following criteria:
-Age: 20 and older
-Written consent has been obtained.
-People without respiratory or systemic symptoms.
-No obvious abnormality on chest radiograph, or a computed tomography scan.
-No underlying disease under treatment or follow-up.
Key exclusion criteria
-Patients with multiple detections of mycobacteria other than MAC.
-Patients with macrolide-resistant MAC detected.
-Patients whose therapy was discontinued due to adverse events, drug interaction, etc.
-Patients who have been treated for less than 12 months.
(If the MAC detected is macrolide susceptible, this criterion is not required.)
-Patients within 1 year of completing prior treatment for MAC-PD.
-Patients who underwent surgery for MAC-PD within 1 year.
-Patients within 1 months of recovery from an acute infection.
-Patients with chronic liver damage due to HBV or HCV.
-HIV-positive patients.
-Patients previously treated with immune checkpoint inhibitors for malignant tumors.
-Patients with active hematologic malignancies.
-Patients after blood stem cell transplants, including bone marrow transplants.
-Patients treated for co-morbidities with high-dose glucocorticoid or immunosuppressive drugs.
-Super-elderly people over 90 years old.
-Pregnant women.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Shindo |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi, 466-8550, Japan
TEL
052-744-2167
yshindo@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Akinobu |
| Middle name | |
| Last name | Matsuura |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi, 466-8550, Japan
TEL
052-744-2167
Homepage URL
akinobu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science, Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Hospital Organization, Higashi-Nagoya Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bioethics Review Committee, Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi, 466-8550, Japan
Tel
052-744/2973
ethics@med.nagoya-u.ac.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
| 2021 | Year | 03 | 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
| 2020 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-This study is an observational study.
-Collection of clinical information and blood samples are performed in both Nagoya University Hospital and Higashi-Nagoya Hospital. Immunological analysis of blood samples is performed in Nagoya University Graduate School of Medicine.
-The protocol was revised to modify the exclusion criteria and to add the healthy subject group, and was re-approved by Institutional Review Board, Nagoya University Hospital on March 24, 2022.
Management information
Registered date
| 2021 | Year | 02 | Month | 24 | Day |
Last modified on
| 2022 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049473
