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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000001955
Receipt No. R000002384
Scientific Title Establishment of respiratory biomarker by metabolome
Date of disclosure of the study information 2009/05/11
Last modified on 2009/05/11

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Basic information
Public title Establishment of respiratory biomarker by metabolome
Acronym Establishment of respiratory biomarker
Scientific Title Establishment of respiratory biomarker by metabolome
Scientific Title:Acronym Establishment of respiratory biomarker
Region
Japan

Condition
Condition lung cancer, bronchial asthma, sleep apnea
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Detect and establish of new respiratory biomaker by metabolome analysis
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes discovery of new protein as respiratory biomaker
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 surgery
Interventions/Control_2 anti cancer drug
Interventions/Control_3 steroid therapy
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
15 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria The patients with lung cancer will be treated with surgery or anti-cancer drug

The patients with asthma will be treated with steroid
Key exclusion criteria the case that the patient does not agree with this study enroll
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyuki Kobayashi
Organization Kobe University Graduate School of Medicine
Division name Division of Respiratory Medicine, Department of Internal Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kobe University Graduate School of Medicine
Division name Division of Respiratory Medicine, Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email kkoba@med.kobe-u.ac.jp

Sponsor
Institute Division of Respiratory Medicine, Department of Internal Medicine,
Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 11 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 Preinitiation
Date of protocol fixation
2009 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 05 Month 11 Day
Last modified on
2009 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002384

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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