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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name