UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluating biomarkers for idiopathic interstitial pneumonia.
Title of the study (Brief title)	New biomarkers for idiopathic interstitial pneumonia.
Region	Japan

Condition
Condition	interstitial pneumonia
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluating lipid mediators and their producing enzymes in serum and BAL fluid from patients with interstitial pneumonia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in concentration according to disease progress.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who are diagnosed as interstitial pneumonia.
Key exclusion criteria	Patients who disagree with involving in this study.
Target sample size	100

Research contact person
Name of lead principal investigator	Hiroshi KUBO
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Advanced Preventive Medicine for Infectious Disease
Address	2-1 Seiryoumachi, Aobaku Sendai JAPAN
TEL	022-717-7174
Email	hkubo@med.tohoku.ac.jp

Public contact
Name of contact person	Hiroshi KUBO
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Advanced Preventive Medicine for Infectious Disease
Address	2-1 Seiryoumachi, Aobaku Sendai JAPAN
TEL	022-717-7184
Homepage URL
Email	hkubo@med.tohoku.ac.jp

Sponsor
Institute	Department of Advanced Preventive Medicine for Infectious Disease, Tohoku University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	National Institute of Biomedical Innovation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Japanese Red-Cross Ishinomaki Hospital
Name of secondary funｄer(s)

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	2011 Year 10 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 10 Month 17 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Sampling is made only from patients who are diagnosed as interstitial pneumonia.

Management information
Registered date	2011 Year 10 Month 17 Day
Last modified on	2016 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007770