UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015080 |
|---|---|
| Receipt number | R000017545 |
| Scientific Title | Development of magnetically promoted rapid diagnostic system using functionalized fluorescent magnetic beads |
| Date of disclosure of the study information | 2014/09/08 |
| Last modified on | 2019/01/31 10:56:36 |
* 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
Development of magnetically promoted rapid diagnostic system using functionalized fluorescent magnetic beads
Acronym
Development of magnetically promoted rapid diagnostic system using functionalized fluorescent magnetic beads
Scientific Title
Development of magnetically promoted rapid diagnostic system using functionalized fluorescent magnetic beads
Scientific Title:Acronym
Development of magnetically promoted rapid diagnostic system using functionalized fluorescent magnetic beads
Region
| Japan |
Condition
Condition
Malignancy, infectious disease
Classification by specialty
| Infectious disease | Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Development of rapid diagnostic system (tumor marker, cytomegalovirus antigenemia)
Basic objectives2
Others
Basic objectives -Others
Assessment of non-inferiority and validity compared with existing diagnostic system
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy
Key secondary outcomes
rapidity
Base
Study type
Others,meta-analysis etc
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
Tumor marker (CEA, CA19-9, AFP) positive case
Cytomegalovirus antigenemia positive case
Key exclusion criteria
Refusal to participate in this clinical trial
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Itano |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
contact@keio-hpbts.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachiko Matsuda |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
matsuda-sa@umin.ac.jp
Sponsor or person
Institute
Toppan printing Co., LTD.
Institute
Department
Personal name
Funding Source
Organization
Toppan printing Co., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2014 | Year | 09 | Month | 08 | 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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not particular
Management information
Registered date
| 2014 | Year | 09 | Month | 07 | Day |
Last modified on
| 2019 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017545
