UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035200 |
|---|---|
| Receipt number | R000040121 |
| Scientific Title | Development of a novel microfluidic device for detecting circulating tumor cells in lung cancer |
| Date of disclosure of the study information | 2018/12/10 |
| Last modified on | 2021/06/15 13:35:19 |
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Basic information
Public title
Development of a novel microfluidic device for detecting circulating tumor cells in lung cancer
Acronym
Microfluidic device for detecting CTCs
Scientific Title
Development of a novel microfluidic device for detecting circulating tumor cells in lung cancer
Scientific Title:Acronym
Microfluidic device for detecting CTCs
Region
| Japan |
Condition
Condition
primary lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Feasibility study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection sensitivity of CTCs
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Histologically/cytologically confirmed lung cancer
Key exclusion criteria
Nothing in particular
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | KOH |
Organization
Wakayama Medical University
Division name
Internal Medicine III
Zip code
641-8509
Address
8-1-1 Kimiiidera, Wakayama
TEL
073-441-0619
ykoh@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | KOH |
Organization
Wakayama Medical University
Division name
Internal Medicine III
Zip code
641-8509
Address
8-1-1 Kimiiidera, Wakayama
TEL
073-441-0619
Homepage URL
ykoh@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical Unviersity
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University
Address
811-1 Kimiidera, Wakayama
Tel
0734410619
ykoh@wakayama-med.ac.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
| 2018 | Year | 12 | Month | 10 | 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
8
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
Terminated
Date of protocol fixation
| 2018 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular
Management information
Registered date
| 2018 | Year | 12 | Month | 10 | Day |
Last modified on
| 2021 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040121
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
