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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041871
Receipt No. 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 2020/09/23

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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
Email 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
Email jm-tkky@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School, Kochi University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study

Management information
Registered date
2020 Year 09 Month 23 Day
Last modified on
2020 Year 09 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047669

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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