UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007916 |
|---|---|
| Receipt number | 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 09:20:24 |
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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
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
masato@ks.kyorin-u.ac.jp
Sponsor or person
Institute
First Department of Internal Medicine, Kyorin University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009295
