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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035447
Receipt No. R000040386
Scientific Title Construction of compound detection system by mass spectrometry for biological samples obtained at Critical Care Center and examination of its operability
Date of disclosure of the study information 2019/01/05
Last modified on 2019/01/05

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Basic information
Public title Construction of compound detection system by mass spectrometry for biological samples obtained at Critical Care Center and examination of its operability
Acronym Construction of compound detection system by mass spectrometry for biological samples obtained at Critical Care Center and examination of its operability
Scientific Title Construction of compound detection system by mass spectrometry for biological samples obtained at Critical Care Center and examination of its operability
Scientific Title:Acronym Construction of compound detection system by mass spectrometry for biological samples obtained at Critical Care Center and examination of its operability
Region
Japan

Condition
Condition Drug intoxication
Classification by specialty
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To construct an identification and concentration measurement system with high performance liquid chromatography - Hybrid Quadrupole-Orbitrap Mass Spectrometer and gas chromatograph mass spectrometer for toxic substances in biological substances from patients in Critical Care Center and to investigate its clinical operability
Basic objectives2 Others
Basic objectives -Others To add new compounds as substances to be detected, and investigate the extensibility of this system
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The type and the frequency of detection of candidate compounds such as toxic substances detected by this system from real clinical biological sample
Key secondary outcomes Difference between toxic substances identified in existing tests and compounds such as toxic substances identified in this system

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients who visited the Advanced Critical Care and Emergency Center in Teikyo University Hospital (including emergency patients)
2.Patients suspected of poisoning, which is written in the medical record.
3.Patient who collected blood or urine for treatment.
Key exclusion criteria 1.Patients or family of whom expressed an intention to refuse to participate in this study.
2.Patients whose residual specimens are inadequate for this study.
3.Those who are judged inappropriate by the investigators.
Target sample size 500

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kiyoko Kaneko
Organization Faculty of Pharma-Science, Teikyo University
Division name Laboratory of Biomedical and Analytical Sciences
Zip code
Address 2-11-1 Kaga Itabashi-ku, Tokyo,173-8605
TEL 03-3964-1211
Email kikaneko@pharm.teikyo-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hiroyuki Hosono
Organization Teikyo University Hospital
Division name Center for Clinical Research & Trial
Zip code
Address 2-11-1 Kaga Itabashi-ku, Tokyo,173-8606
TEL 03-3964-1211
Homepage URL
Email hhosono@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University
Institute
Department

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

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 帝京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 05 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 Open public recruiting
Date of protocol fixation
2018 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 16 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational research using residual specimens

Management information
Registered date
2019 Year 01 Month 05 Day
Last modified on
2019 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040386

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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