UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014502
Receipt No. R000016869
Scientific Title Screening of biomarkers using gene expression profiling in peripheral blood of severely septic patients
Date of disclosure of the study information 2014/07/07
Last modified on 2020/07/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Screening of biomarkers using gene expression profiling in peripheral blood of severely septic patients
Acronym Gene expression profiling in peripheral blood of severe sepsis
Scientific Title Screening of biomarkers using gene expression profiling in peripheral blood of severely septic patients
Scientific Title:Acronym Gene expression profiling in peripheral blood of severe sepsis
Region
Japan

Condition
Condition Severe sepsis
Classification by specialty
Medicine in general Infectious disease Surgery in general
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To detect sepsis-associated biomarkers with gene expression profiling and to analyze the significant alteration of time-dependent expression
Basic objectives2 Others
Basic objectives -Others Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Significant alteration of time-dependent expression in severe sepsis
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Adult patients with severe sepsis
Key exclusion criteria Patients who are onsidered inappropriate
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Eizo
Middle name
Last name Watanabe
Organization Graduate School of Medicine, Chiba University
Division name Department of General Medical Science
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba Prefecture
TEL +81-43-226-2823
Email watanabee@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Eizo
Middle name
Last name Watanabe
Organization Graduate School of Medicine, Chiba University
Division name Department of General Medical Science
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba Prefecture
TEL +81-43-226-2823
Homepage URL
Email watanabee@faculty.chiba-u.jp

Sponsor
Institute Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization Fukushima Translational Research Project
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Fukushima Medical University
Asahi Kasei Pharma Corporation
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethics Committee of Chiba University School of Medicine
Address 1-8-1, Inohana, Chuo-ku
Tel +81432262372
Email igaku-seimei@office.chiba-u.jp

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
2014 Year 07 Month 07 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 40
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason Reconsidering the methods for data analyses
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 No longer recruiting
Date of protocol fixation
2013 Year 11 Month 08 Day
Date of IRB
2013 Year 11 Month 08 Day
Anticipated trial start date
2013 Year 11 Month 08 Day
Last follow-up date
2016 Year 04 Month 30 Day
Date of closure to data entry
2016 Year 04 Month 30 Day
Date trial data considered complete
2018 Year 07 Month 08 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information To detect sepsis-associated biomarkers with gene expression profiling and to analyze the significant alteration of time-dependent expression. Additionally to evaluate association between the gene expression profiling and the selected inflammation-related genetic polymorphisms.

Management information
Registered date
2014 Year 07 Month 07 Day
Last modified on
2020 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016869

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.