UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020846 |
|---|---|
| Receipt number | 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 15:49:10 |
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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
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
katsuyas@z5.keio.jp
Sponsor or person
Institute
Keio university school of medicine, division of rheumatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020960
