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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020846
Receipt No. R000020960
Scientific Title Clinical study for establishment of novel minimal invasive needle microsampling analysis .
Date of disclosure of the study information 2016/02/03
Last modified on 2016/02/02

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Basic information
Public title Clinical study for establishment of novel minimal invasive needle microsampling analysis .
Acronym Clinical study for establishment of novel minimal invasive needle microsampling analysis .
Scientific Title Clinical study for establishment of novel minimal invasive needle microsampling analysis .
Scientific Title:Acronym Clinical study for establishment of novel minimal invasive needle microsampling analysis .
Region
Japan

Condition
Condition None
Classification by specialty
Clinical immunology Not applicable
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To validate the newest, non-invasive needle for blood collection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Comparison safety (VAS of Pain and general) and Efficacy (sampling time, amount and quality of RNA / DNA and protein assay etc.) between blood sampling using nobel extrafine needle and that in coventional method.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Newer and ordinary fine needle blood sampling
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy volunteer
Key exclusion criteria persons who did not acceptable for informed concent and inadequate for this the trial by doctor.
Target sample size 7

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Takeuchi
Organization Keio university scoole of medicine
Division name Division of Rheumatology
Zip code
Address 35 Shinanomchi Shinjuku-ku, Tokyo
TEL 0333531211
Email tsutake@a5.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuya Suzuki
Organization Keio university school of medicine
Division name Division of Rheumatology
Zip code
Address 35 Shinanomchi Shinjuku-ku, Tokyo
TEL 0333531211
Homepage URL
Email katsuyas@z5.keio.jp

Sponsor
Institute Keio university school of medicine, division of rheumatology
Institute
Department

Funding Source
Organization MHLW
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor DNA CHIP Research Inc.
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
2016 Year 02 Month 03 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 No longer recruiting
Date of protocol fixation
2013 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 01 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 01 Month 31 Day
Date trial data considered complete
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 02 Month 02 Day
Last modified on
2016 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020960

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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