UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025724 |
|---|---|
| Receipt number | R000029584 |
| Scientific Title | A novel technique for cellular diagnosis utilizing scanning electron microscope. |
| Date of disclosure of the study information | 2017/01/24 |
| Last modified on | 2020/05/12 12:14:40 |
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Basic information
Public title
A novel technique for cellular diagnosis utilizing scanning electron microscope.
Acronym
A novel technique utilizing scanning electron microscope.
Scientific Title
A novel technique for cellular diagnosis utilizing scanning electron microscope.
Scientific Title:Acronym
A novel technique utilizing scanning electron microscope.
Region
| Japan |
Condition
Condition
thoracic malignancy
Classification by specialty
| Chest surgery | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the distinguishability of tumor cells by intracellular observation and elemental analysis method using tabletop electron microscope
Basic objectives2
Others
Basic objectives -Others
distinguishability of tumor cells
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
distinguishability of tumor cells
Key secondary outcomes
background factor
optimal observation method
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
Patients who underwent surgery for diseases that had been suspected thoracic malignancy in National Cancer Center Hospital from May 2015 to July 2016.
Patients who agreed the comprehensive content.
Key exclusion criteria
not applicable
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Matsumoto |
Organization
National Cancer Center Hospital
Division name
Department of Endoscopy, Respiratory Endoscopy Division
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
yumatsum@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Matsumoto |
Organization
National Cancer Center Hospital
Division name
Department of Endoscopy, Respiratory Endoscopy Division
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
yumatsum@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Hitachi Ltd.
Hitachi High-Technologies
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
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
irst@ml.res.ncc.go.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
| 2017 | Year | 01 | Month | 24 | 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
| 2016 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not applicable
Management information
Registered date
| 2017 | Year | 01 | Month | 18 | Day |
Last modified on
| 2020 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029584
