UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006557
Receipt number R000007770
Scientific Title Evaluating biomarkers for idiopathic interstitial pneumonia.
Date of disclosure of the study information 2011/10/20
Last modified on 2016/04/17 09:16:02

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Basic information

Public title

Evaluating biomarkers for idiopathic interstitial pneumonia.

Acronym

New biomarkers for idiopathic interstitial pneumonia.

Scientific Title

Evaluating biomarkers for idiopathic interstitial pneumonia.

Scientific Title:Acronym

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



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 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

1st name
Middle name
Last name Hiroshi KUBO

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Advanced Preventive Medicine for Infectious Disease

Zip code


Address

2-1 Seiryoumachi, Aobaku Sendai JAPAN

TEL

022-717-7174

Email

hkubo@med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi KUBO

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Advanced Preventive Medicine for Infectious Disease

Zip code


Address

2-1 Seiryoumachi, Aobaku Sendai JAPAN

TEL

022-717-7184

Homepage URL


Email

hkubo@med.tohoku.ac.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Completed

Date of protocol fixation

2011 Year 10 Month 17 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007770