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 2022/10/19 10:57:40

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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 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

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

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

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

2022 Year 10 Month 19 Day



Link to view the page

Value
https://center6.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