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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007916
Receipt No. R000009295
Scientific Title The Analysis of Serum/Plasma Biomakers In Patients With Infectious Diseases.
Date of disclosure of the study information 2012/05/09
Last modified on 2018/11/13

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Basic information
Public title The Analysis of Serum/Plasma Biomakers In Patients With Infectious Diseases.
Acronym The Analysis of Serum/Plasma Biomakers In Patients With Infectious Diseases.
Scientific Title The Analysis of Serum/Plasma Biomakers In Patients With Infectious Diseases.
Scientific Title:Acronym 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
1st name
Middle name
Last name Masato Watanabe
Organization Kyorin University School of Medicine

Division name First Department of Internal 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 School of Medicine
Division name First Department of Internal 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 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)

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
2012 Year 05 Month 09 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
2008 Year 07 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000009295

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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