UMIN-CTR Clinical Trial

Basic information
Public title	Analytical study of cytokines and chemokines in stored BALF in patients with acute exacerbation of fibrosing interstitial lung disease.
Acronym	Biomarker study in stored BALF in patients with acute exacerbation of fibrosing interstitial lung disease.
Scientific Title	Analytical study of cytokines and chemokines in stored BALF associated with acute exacerbation of fibrosing interstitial lung disease.
Scientific Title:Acronym	Biomarker study in stored BALF in patients with acute exacerbation of fibrosing interstitial lung disease.
Region	Japan

Condition
Condition	Acute exacerbation of fibrosing interstitial lung disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Analysis of cytokines in BAL during acute exacerbations to search for factors associated with prognosis and treatment response.
Basic objectives2	Others
Basic objectives -Others	None
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate the relationship between biomarkers in BALF and prognosis and treatment response.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who enrolled in the "Acute exacerbation of fibrosing interstitial lung disease; multicenter retrospective cohort study" and who underwent BAL and had preserved specimens.
Key exclusion criteria	Cases in which the subject refuses to provide information Cases in which BAL specimens are not stored.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Daichi Middle name Last name Hujimoto
Organization	Wakayama Medical University
Division name	Department of Pulmonary Medicine and Medical Oncology
Zip code	641-8509
Address	811-1, Kimiidera, Wakayama City
TEL	073-441-0619
Email	daichi@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Katsuyuki Middle name Last name Furuta
Organization	Wakayama Medical University
Division name	Department of Pulmonary Medicine and Medical Oncology
Zip code	641-8509
Address	811-1, Kimiidera, Wakayama City
TEL	073-441-0619
Homepage URL
Email	k-furuta@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Boehringer Ingelheim
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Ethics Committee of Wakayama Medical University
Address	811-1 Kimiidera, Wakayama, Wakayama Prefecture
Tel	073-447-2300
Email	wa-rinri@wakayama-med.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	神戸市立医療センター中央市民病院(兵庫県)、和歌山県立医科大学附属病院(和歌山県)

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 17 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 14 Day
Date of IRB	2020 Year 12 Month 07 Day
Anticipated trial start date	2020 Year 12 Month 07 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	By analyzing biomarkers in BAL of patients with acute exacerbation of fibrosing interstitial lung disease, we will conduct this study to explore prognostic factors and improve treatment in this disease.

Management information
Registered date	2021 Year 01 Month 17 Day
Last modified on	2021 Year 01 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049126