UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050641 |
|---|---|
| Receipt number | R000057690 |
| Scientific Title | Study on pulmonary parenchymal destruction in bronchial asthma |
| Date of disclosure of the study information | 2023/03/21 |
| Last modified on | 2024/03/24 11:31:17 |
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Basic information
Public title
Study on pulmonary parenchymal destruction in bronchial asthma
Acronym
Study on pulmonary parenchymal destruction in bronchial asthma
Scientific Title
Study on pulmonary parenchymal destruction in bronchial asthma
Scientific Title:Acronym
Study on pulmonary parenchymal destruction in bronchial asthma
Region
| Japan |
Condition
Condition
Study on pulmonary parenchymal destruction in asthma
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the parenchymal destruction on preoperative CT in patients with any respiratory disease other than puomonary nodules, non-smokers with asthma, smokers with asthma and chronic obstructive pulmonary disease (COPD) who have undergone lung resection of more than one area due to local lesions such as lung cancer, and to compare pathology (including micro-CT) and molecular biology in the lungs.
Basic objectives2
Others
Basic objectives -Others
biology and molecular biology
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
CT pulmonary parenchymal destruction index (Exponent D, low attenuation area percent), pathological index (alveolar space length (mean linear intercept), number of alveolar attachments, number of terminal bronchioles) in resected lung specimens
Key secondary outcomes
Exploratory evaluation using mRNA microarray, Pulmonary elastic fiber-related factors including collagen I, collagen III, fibronectin, matrix metalloproteinase (MMP)-1,MMP-2, MMP-9, tissue inhibitor of metalloproteinase (TIMP)
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
Patients who have undergone a lung resection of more than one area due to local lesions such as lung cancer between 2006 and November 30, 2021 at the Department of Respiratory Surgery, Hokkaido University Hospital will be eligible for this study.
(1) Patients who have no respiratory disease other than the primary disease of surgery, or who have asthma or COPD as a complication.
(2) Those who have given their free and voluntary consent to participate in this study, or those who have not received any refusal from the research subjects or those who are considered to represent the will and interests of the research subjects with regard to participation in this study.
Translated with DeepL
Key exclusion criteria
1 Those who have a complication of respiratory disease other than the present illness of surgery, asthma, or COPD.
2 Those deemed inappropriate as subjects by the principal investigator
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Kaoruko |
| Middle name | |
| Last name | Shimizu |
Organization
Hokkaido University
Division name
Graduate school of medicine, school of medicine, Respiratory Medicine
Zip code
060-8638
Address
West 5, North 15, Kita-ku, Sapporo
TEL
+81117065911
kaorukoshimizu@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Kaoruko |
| Middle name | |
| Last name | Shimizu |
Organization
Hokkaido University
Division name
Graduate School of Medicine, School of Medicine, Respiratory Medicine
Zip code
060-8638
Address
West 7, North 15, Kita-ku, Sapporo
TEL
+81117065911
Homepage URL
kaorukoshimizu@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office of IRB, Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital
Address
West 5, North 15, Kita-ku, Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 21 | 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
| 2022 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
The study will be finalized by the time when the examination on pathological and molecular biology in the participants.
Management information
Registered date
| 2023 | Year | 03 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057690
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
