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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Interstitial lung diseases | |
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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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. |
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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. |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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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 | |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Recruitment status | Preinitiation | ||||||
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Other related information | observational study |
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Last modified on |
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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 | |
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Research case data | |
Registered date | File name |