UMIN-CTR Clinical Trial

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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