UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049279 |
|---|---|
| Receipt number | R000056118 |
| Scientific Title | A QOL-Value Survey for Quality-Adjusted Life-Year (QALY) Estimation for Pulmonary Mycobacterium avium complex Pulmonary Disease (MAC-PD). |
| Date of disclosure of the study information | 2022/10/22 |
| Last modified on | 2022/10/20 18:01:34 |
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Basic information
Public title
A QOL Value Survey for Quality-Adjusted Life Year (QALY) Estimation for MAC Pulmonary Disease (MAC-PD)
Acronym
A QOL Value Survey for Quality-Adjusted Life Year (QALY) Estimation for MAC Pulmonary Disease (MAC-PD)
Scientific Title
A QOL-Value Survey for Quality-Adjusted Life-Year (QALY) Estimation for Pulmonary Mycobacterium avium complex Pulmonary Disease (MAC-PD).
Scientific Title:Acronym
A QOL Value Survey for QALY Estimation for MAC-PD
Region
| Japan |
Condition
Condition
Non-tuberculous mycobacterial pulmonary disease (NTM-PD) caused by Mycobacterium avium complex (MAC)
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the effect of increasing or decreasing the severity of MAC pulmonary disease (MAC-PD) and the symptoms associated with negative sputum cultures and the burden on daily life on the QOL value for the relevant health condition based on the responses obtained from a questionnaire survey of the general population, and to quantify the health economics value of each condition.
Basic objectives2
Others
Basic objectives -Others
QOL survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL values by severity in patients with MAC-PD.
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) General adults aged 20 years or older at screening
(2) Individuals who are judged by the investigator to have adequate understanding of the conduct of the study
(3) Those who agreed to participate in the study.
(4) Persons who can complete the protocol-specified procedures
(5) Individuals living in Japan at the time of screening
Key exclusion criteria
(1) Patients who have difficulty obtaining informed consent and conducting this study due to lack of Japanese language ability
(2) Individuals who cannot participate in the survey
Target sample size
319
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Sakamoto |
Organization
Insmed GK
Division name
Research and Development and Medical Affairs
Zip code
100-0014
Address
1-10-3 Nagata-cho, Chiyoda-ku, Tokyu capitol Tower 13F
TEL
03-4232-2191
hideki.sakamoto@Insmed.com
Public contact
Name of contact person
| 1st name | Tatsunori |
| Middle name | |
| Last name | Murata |
Organization
CRECON Medical Assessment Inc.
Division name
NA
Zip code
150-0002
Address
The Pharmaceutical Society of Japan, Nagai Memorial 12-15, Shibuya 2-chome, Shibuya-ku, Tokyo
TEL
03-3407-4491
Homepage URL
Tatsunori.murata@crecon.jp
Sponsor or person
Institute
Insmed GK
Institute
Department
Personal name
Funding Source
Organization
Insmed GK
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization, MINS Research Ethics Committee
Address
20-9-401, 5-chome, Mita, Minato-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2022 | Year | 10 | Month | 22 | 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
319
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
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The time trade-off (TTO) method is used in this study.
Management information
Registered date
| 2022 | Year | 10 | Month | 20 | Day |
Last modified on
| 2022 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056118
