UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049259 |
|---|---|
| Receipt number | R000056097 |
| Scientific Title | Search for potential relationships between genetic polymorphism and pulmonary fibrosis after COVID-19 disease |
| Date of disclosure of the study information | 2022/10/20 |
| Last modified on | 2022/10/18 21:16:15 |
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Basic information
Public title
Search for potential relationships between genetic polymorphism and pulmonary fibrosis after COVID-19 disease
Acronym
Potential relationships between pulmonary fibrosis after COVID-19 disease and genetic polymorphism
Scientific Title
Search for potential relationships between genetic polymorphism and pulmonary fibrosis after COVID-19 disease
Scientific Title:Acronym
Potential relationships between pulmonary fibrosis after COVID-19 disease and genetic polymorphism
Region
| Japan |
Condition
Condition
Coronavirus disease of 2019 (COVID-19)
Classification by specialty
| Pneumology | Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the role of inborn mutations of genes as a biomarker of pulmonary fibrosis after COVID19 disease.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of pulmonary fibrosis by types of gene mutations
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who had a chest CT scan three and more months after COVID-19 disease
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kawasaki |
Organization
Chiba University
Division name
Department of Respirology, Graduate School of Medicine
Zip code
260-8670
Address
1-8-1, Inohana, Chuoku, Chiba, Chiba
TEL
043-222-7171
kawatake@chiba-u.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kawasaki |
Organization
Chiba University
Division name
Department of Respirology, Graduate School of Medicine
Zip code
260-8670
Address
1-8-1, Inohana, Chuoku, Chiba, Chiba
TEL
043-222-7171
Homepage URL
kawatake@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University
Address
1-8-1, Inohana, Chuoku, Chiba, Chiba
Tel
043-222-7171
kawatake@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
| 2022 | Year | 10 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 10 | Month | 19 | Day |
Last modified on
| 2022 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056097
