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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020502
Receipt No. R000023612
Scientific Title Clinical study for evaluating serum/plasma biomarker levels of healthy subjects to compare with these of patients with lung diseases.
Date of disclosure of the study information 2016/02/01
Last modified on 2016/04/26

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Basic information
Public title Clinical study for evaluating serum/plasma biomarker levels of healthy subjects to compare with these of patients with lung diseases.
Acronym Biomarkers in healthy subjects.
Scientific Title Clinical study for evaluating serum/plasma biomarker levels of healthy subjects to compare with these of patients with lung diseases.
Scientific Title:Acronym Biomarkers in healthy subjects.
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Medicine in general Pneumology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare serum/plasma biomarker levels of healthy subjects to lung disease patients.
Basic objectives2 Others
Basic objectives -Others Explorative research for biomarkers.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Biomarker levels
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy subjects
Key exclusion criteria
Subjects who have no consent ability.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Watanabe
Organization Kyorin University
Division name Department of respiratory medicine
Zip code
Address 6-20-2 Shinkawa, Mitaka-city, Tokyo 181-8611 Japan
TEL 0422-47-5511
Email masato@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masato Watanabe
Organization Kyorin University
Division name epartment of respiratory medicine
Zip code
Address 6-20-2 Shinkawa, Mitaka-city, Tokyo 181-8611 Japan
TEL 0422-47-5511
Homepage URL
Email masato@ks.kyorin-u.ac.jp

Sponsor
Institute Department of Respiratory Medicine, Kyorin University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kosei Hospital, Nomura Hospital, Morimoto Hospital, Jiundoh Hospital, or Kurai Naika Clinic, who meet to our inclusion criteria, and who provide us a written informed consent.

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
2016 Year 02 Month 01 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
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 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 An observational study of healthy volunteers (case control study comparing to patients with respiratory disease).

We will obtain serum/plasma sample from donors (without respiratory diseases) who visit Kyorin University Hospital, Kousei Hospital, Nomura Hospital, Morimoto Hospital, Jiundoh Hospital, or Kurai Naika Clinic, Yasaka Kinen Hospital, who meet to our inclusion criteria, and who provide us a written informed consent.

We will measure serum/plasma levels of biomarkers for lung diseases (i.e. IL-8, IL-6, sST2, LL-37, IL-33, carnitine, H2O2, and others).

Management information
Registered date
2016 Year 01 Month 08 Day
Last modified on
2016 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023612

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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