UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Analysis of Serum/Plasma Biomakers In Patients With Infectious Diseases.
Title of the study (Brief title)	The Analysis of Serum/Plasma Biomakers In Patients With Infectious Diseases.
Region	Japan

Condition
Condition	Patients with infectious diseases Patients with non-infectious lung diseases Healthy individuals Patients with collagen vascular diseases
Classification by specialty	Medicine in general Pneumology Clinical immunology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Exploration and function analysis of biomarkers related with infectious diseases.
Basic objectives2	Others
Basic objectives -Others	In order to explore biomarkers for diagnosis of infectious diseases, evaluation of disease activity and determination of treatment efficacies, we will examine materials in sera/plasma from patients with infectious diseases. As controls, sera/plasma from healthy individuals, patients with non-infectious lung diseases and collagen-vascular diseases would also be analyzed.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Exploration of novel biomarkers.
Key secondary outcomes	Function analysis of the newly explored biomakers

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 infectious disease Patients with non-infectious lung disease Healthy individuals Patients with collagen-vascular diseases
Key exclusion criteria	Patients with HIV infection. Patients with non-informed malignant neoplasms.
Target sample size	300

Research contact person
Name of lead principal investigator	Masato Watanabe
Organization	Kyorin University School of Medicine
Division name	First Department of Internal 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 School of Medicine
Division name	First Department of Internal 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	First Department of Internal Medicine, Kyorin University School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology in Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2012 Year 05 Month 09 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2008 Year 07 Month 01 Day
Anticipated trial start date	2008 Year 07 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	This is a prospective observational study in order to explore biomarkers for diagnosing infectious diseases, evaluating disease activity and determining treatment efficacies. As control groups, healthy individuals, patients with non-infectious lung diseases and collagen-vascular diseases would also be analyzed.

Management information
Registered date	2012 Year 05 Month 09 Day
Last modified on	2018 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009295