UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043034 |
|---|---|
| Receipt number | R000049126 |
| Scientific Title | Analytical study of cytokines and chemokines in stored BALF associated with acute exacerbation of fibrosing interstitial lung disease. |
| Date of disclosure of the study information | 2021/01/17 |
| Last modified on | 2021/01/17 00:14:19 |
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Basic information
Public title
Analytical study of cytokines and chemokines in stored BALF in patients with acute exacerbation of fibrosing interstitial lung disease.
Acronym
Biomarker study in stored BALF in patients with acute exacerbation of fibrosing interstitial lung disease.
Scientific Title
Analytical study of cytokines and chemokines in stored BALF associated with acute exacerbation of fibrosing interstitial lung disease.
Scientific Title:Acronym
Biomarker study in stored BALF in patients with acute exacerbation of fibrosing interstitial lung disease.
Region
| Japan |
Condition
Condition
Acute exacerbation of fibrosing interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of cytokines in BAL during acute exacerbations to search for factors associated with prognosis and treatment response.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the relationship between biomarkers in BALF and prognosis and treatment response.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who enrolled in the "Acute exacerbation of fibrosing interstitial lung disease; multicenter retrospective cohort study" and who underwent BAL and had preserved specimens.
Key exclusion criteria
Cases in which the subject refuses to provide information
Cases in which BAL specimens are not stored.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Daichi |
| Middle name | |
| Last name | Hujimoto |
Organization
Wakayama Medical University
Division name
Department of Pulmonary Medicine and Medical Oncology
Zip code
641-8509
Address
811-1, Kimiidera, Wakayama City
TEL
073-441-0619
daichi@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Furuta |
Organization
Wakayama Medical University
Division name
Department of Pulmonary Medicine and Medical Oncology
Zip code
641-8509
Address
811-1, Kimiidera, Wakayama City
TEL
073-441-0619
Homepage URL
k-furuta@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Boehringer Ingelheim
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
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture
Tel
073-447-2300
wa-rinri@wakayama-med.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
神戸市立医療センター中央市民病院(兵庫県)、和歌山県立医科大学附属病院(和歌山県)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 17 | 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 | 09 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 07 | 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
By analyzing biomarkers in BAL of patients with acute exacerbation of fibrosing interstitial lung disease, we will conduct this study to explore prognostic factors and improve treatment in this disease.
Management information
Registered date
| 2021 | Year | 01 | Month | 17 | Day |
Last modified on
| 2021 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049126
