UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study for evaluating serum/plasma biomarker levels of healthy subjects to compare with these of patients with lung diseases.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Masato Watanabe
Organization	Kyorin University
Division name	Department of respiratory medicine
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	Masato Watanabe
Organization	Kyorin University
Division name	epartment of respiratory medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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