UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019433 |
|---|---|
| Receipt number | 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 14:41:39 |
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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
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
k2684@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022477
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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