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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028108
Receipt No. R000032170
Scientific Title Discovery of Novel Biomarkers in Pulmonary Diseases
Date of disclosure of the study information 2017/07/07
Last modified on 2017/08/21

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Basic information
Public title Discovery of Novel Biomarkers in Pulmonary Diseases
Acronym Novel Biomarkers in Pulmonary Diseases
Scientific Title Discovery of Novel Biomarkers in Pulmonary Diseases
Scientific Title:Acronym Novel Biomarkers in Pulmonary Diseases
Region
Japan

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

Objectives
Narrative objectives1 Discovery of novel biomarker discovery in pulmonary diseases
Basic objectives2 Others
Basic objectives -Others Search for effects of therapeutic intervention on biomarkers
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Association with disease severity and prognosis
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with pulmonary diseases
Key exclusion criteria Patients who did not obtain consent for blood collection
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Suda
Organization Hamamatsu University School Of Medicine
Division name Second division, department of internal medicine
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3129 Japan
TEL +81-53-435-2263
Email skato@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinpei Kato
Organization Hamamatsu University School of Medicine
Division name Second division, department of internal medicine
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3129 Japan
TEL +81-53-435-2263
Homepage URL
Email skato@hama-med.ac.jp

Sponsor
Institute Second division, department of internal medicine, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Hamamatsu University School of Medicine
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

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 07 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
2017 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: Case control study
Objective: Patients with pulmonary diseases
Measurements: Blood, Sputum, Broncho-alveolar lavage

Management information
Registered date
2017 Year 07 Month 06 Day
Last modified on
2017 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032170

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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