UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041871 |
|---|---|
| Receipt number | R000047669 |
| Scientific Title | A prospective observational study on mechanism of pulmonary fibrosis and a signature molecule based on pathology of progressive fibrosing interstitial lung diseases |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2024/03/29 09:56:54 |
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Basic information
Public title
A prospective observational study on mechanism of pulmonary fibrosis and a signature molecule based on pathology of progressive fibrosing interstitial lung diseases
Acronym
A prospective observational study on mechanism of pulmonary fibrosis and a signature molecule based on pathology of progressive fibrosing interstitial lung diseases
Scientific Title
A prospective observational study on mechanism of pulmonary fibrosis and a signature molecule based on pathology of progressive fibrosing interstitial lung diseases
Scientific Title:Acronym
A prospective observational study on mechanism of pulmonary fibrosis and a signature molecule based on pathology of progressive fibrosing interstitial lung diseases
Region
| Japan |
Condition
Condition
Interstitial lung diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Interstitial lung diseases (ILDs) have a similar clinical phenotype progressive fibrosing ILD (PF-ILD) regardless of etiology and/or pathophysiology of underlying primary diseases. PF-ILD is defined as having the features of increased fibrotic opacities on chest computed tomography, progressive declines of lung function, and poor prognosis. For such patients, antifibrotic drugs such as nintedanib or pirfenidone have been found to be more effective than anti-inflammatory drugs such as corticosteroids and/or immunosuppressants.In clinical practice, differentiation of fibrotic phenotypes (progressive or non-progressive) and/or inflammatory phenotypes (chronic inflammatory or acute exacerbation) and early intervention are considered to be more important to improve the prognosis of PF-ILD. The purpose of this prospective observational study is to elucidate the mechanism related to progressive pulmonary fibrosis and to discover signature cells and molecules of PF-ILD by using flow cytometry.
Basic objectives2
Others
Basic objectives -Others
The differences in subsets and activation of T cells, B cells, macrophages, and granulocytes in bronchoalveolar lavage fluid and peripheral blood is compared with or without pulmonary fibrosis. Investigate the relationship between such deviation on cellular subsets and/or activation with later prognosis of ILD patients at 12 months.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The differences in subsets and activation of T cells, B cells, macrophages, and granulocytes in bronchoalveolar lavage fluid and peripheral blood is compared with or without pulmonary fibrosis. Investigate the relationship between such deviation on cellular subsets and/or activation with later prognosis of ILD patients at 12 months.
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. Patients with interstitial lung disease
s (ILDs)
In patients with acute phase,treated o
r untreated are eligible.
In patients with chronic disease,untrea
ted are eligible.
2. Participants must be fully informed abo
ut the study and signed a written infor
med consent.
Key exclusion criteria
1. Cases not possible to cooperate with ex
aminations such as pulmonary function t
ests.
2. Cases with active respiratory infectio
n.
3. Cases in which informed consent was obt
ained for this study.
4. Cases judged by the attending physicia
n to be an ineligible.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ohnishi |
Organization
Kochi Medical School, Kochi University
Division name
Department of Respiratory Medicine and Allergology
Zip code
783-8505
Address
Oko-cho, Kohasu, Nankoku, Kochi, 783-8505, Japan
TEL
088-880-2345
honi@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsukie |
| Middle name | |
| Last name | Tsukuda |
Organization
Kochi Medical School, Kochi University
Division name
Department of Respiratory Medicine and Allergology
Zip code
783-8505
Address
Oko-cho, Kohasu, Nankoku, Kochi, 783-8505, Japan
TEL
088-880-2345
Homepage URL
jm-tkky@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
Center for Intractable Immune Disease, Kochi Medical School, Kochi
University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Respiratory Medicine and Allergology, Kochi Medical School, Kochi University
Address
Oko-cho, Kohasu, Nankoku, Kochi, 783-8505, Japan
Tel
088-880-2345
jm-tkky@kochi-u.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 01 | 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 | 30 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
observational study
Management information
Registered date
| 2020 | Year | 09 | Month | 23 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047669
