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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019433
Receipt No. R000022477
Scientific Title Evaluation of the roles as the biomarker of the nitric oxide in Japanese patients with respiratory diseases
Date of disclosure of the study information 2015/10/26
Last modified on 2015/10/26

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Basic information
Public title Evaluation of the roles as the biomarker of the nitric oxide in Japanese patients with respiratory diseases
Acronym The role of NO in respiratory diseases
Scientific Title Evaluation of the roles as the biomarker of the nitric oxide in Japanese patients with respiratory diseases
Scientific Title:Acronym The role of NO in respiratory diseases
Region
Japan

Condition
Condition respiratory diseases
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We measure nitric oxide (NOx) of the serum, bronchoalveolar lavage fluid and expiration in order to clarify the role and the significance of newly biomarker of NO in the clinical condition of various respiratory disease (interstitial pneumonia, lung cancer, respiratory infection, bronchial asthma, chronic obstructive pulmonary disease) Therefore, we perform comparison between the level of NOx and a clinical parameter, severity, clinical coarse and a prognosis.
Basic objectives2 Others
Basic objectives -Others The significance as biomarker
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of the NOx level in every respiratory diseases
Key secondary outcomes Comparison between the NOx level and the fibrotic severity of interstitial pneumonia
Comparison between the NOx level and the staging of lung cancer

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 The patient with respiratory disease (interstitial pneumonia, lung cancer, respiratory infection, bronchial asthma, chronic obstructive pulmonary disease)
Key exclusion criteria Less than 20 years old
The patient who are already treated with the respiratory disease
The patient who are treated with hypertension, chronic heart failure, diabetes, and/or hyperlipidemia
The patients with are already administerd of steroid, immunosuppressive drug, and/or antibiotics
The patient with serious liver dysfunction and/or renal dysfunction
The patient who judged to be inappropriate for the study by attending physician
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Noguchi
Organization University of Occupational and Environmental Health, Japan
Division name Department of Respiratory Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishiku, Kitakyushu city, Fukuoka, 807-8555, Japan
TEL +81-93-691-7453
Email k2684@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Noguchi
Organization University of Occupational and Environmental Health, Japan
Division name Department of Respiratory Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishiku, Kitakyushu city, Fukuoka, 807-8555, Japan
TEL +81-93-691-7453
Homepage URL
Email k2684@med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization University of Occupational and Environmental Health, Japan
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 産業医科大学病院 呼吸器内科

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 26 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
2015 Year 06 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is prospective cohot study.The patients which admitte our or reffered hospital from Oct 26th, 2015 to March, 2-17 and are equal with the criteria will be enrolled.

Management information
Registered date
2015 Year 10 Month 21 Day
Last modified on
2015 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022477

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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