UMIN-CTR Clinical Trial

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	2022 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	2022 Year 01 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016869