UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043539 |
|---|---|
| Receipt number | R000049717 |
| Scientific Title | Multicenter study for elucidating the pathophysiology of respiratory diseases using integrative omics analysis including the TGFb signal transduction system and genetic information analysis |
| Date of disclosure of the study information | 2021/03/09 |
| Last modified on | 2021/03/06 11:59:32 |
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Basic information
Public title
Multicenter study for elucidating the pathophysiology of respiratory diseases using integrative omics analysis including the TGFb signal transduction system and genetic information analysis
Acronym
Multicenter study for elucidating the pathophysiology of respiratory diseases using integrative omics analysis including the TGFb signal transduction system and genetic information analysis
Scientific Title
Multicenter study for elucidating the pathophysiology of respiratory diseases using integrative omics analysis including the TGFb signal transduction system and genetic information analysis
Scientific Title:Acronym
Multicenter study for elucidating the pathophysiology of respiratory diseases using integrative omics analysis including the TGFb signal transduction system and genetic information analysis
Region
| Japan |
Condition
Condition
respiratory diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Elucidation of the pathobiology of respiratory diseases using integrative omics analysis including the TGFb signal transduction system
Basic objectives2
Others
Basic objectives -Others
Involvement of genetic factors in the pathophysiology of respiratory diseases
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Elucidation of genetic predisposition
Key secondary outcomes
Elucidation of molecular pathobiology related to etiology and pathophysiology using blood samples and alveolar lavage fluid samples
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Blood sample collection and bronchoalveolar lavage fluid collection
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with confirmed diagnosis of respiratory diseases
2. Patients with suspected respiratory diseases
3. Relatives of 1
Key exclusion criteria
patients who are supposed to be unsuitable for this study by a study director
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Tatsumi |
Organization
Medical Mycology Research Center, Chiba University
Division name
Division of Respiratory Molecular Medicine
Zip code
2608677
Address
1-8-1 Inohana Chuo-ku, Chiba city, Chiba, Japan
TEL
043-222-7171
tatsumi@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Shigeta |
Organization
Graduate School of Medicine Chiba University
Division name
Department of Respirology
Zip code
2608670
Address
1-8-1 Inohana Chuo-ku, Chiba city, Chiba, Japan
TEL
043-222-7171
Homepage URL
aya0107@chiba-u.jp
Sponsor or person
Institute
Department of Respirology, Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medicine Chiba University
Address
1-8-1 Inohana Chuo-ku, Chiba city, Chiba, Japan
Tel
0432227171
inohana-seimei@chiba-u.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 | 09 | 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 | 12 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 07 | Day |
Last modified on
| 2021 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049717
