UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012488 |
|---|---|
| Receipt number | R000014536 |
| Scientific Title | Evaluation and molecular analysis of circulating tumor cells using the On-chip Sort for patients with non-small cell lung cancer |
| Date of disclosure of the study information | 2013/12/04 |
| Last modified on | 2019/12/09 19:51:42 |
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Basic information
Public title
Evaluation and molecular analysis of circulating tumor cells using the On-chip Sort for patients with non-small cell lung cancer
Acronym
Evaluation and molecular analysis of CTCs using the On-chip Sort for patients with NSCLC
Scientific Title
Evaluation and molecular analysis of circulating tumor cells using the On-chip Sort for patients with non-small cell lung cancer
Scientific Title:Acronym
Evaluation and molecular analysis of CTCs using the On-chip Sort for patients with NSCLC
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To perform the evaluation and molecular analysis of circulating tumor cells using the On-chip Sort for patients with non-small cell lung cancer. In addition, we will compare the sensitivity of On-chip Sort system with the CellSearch system.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of CTCs using the On-chip Sort
Key secondary outcomes
Association between CTCs count and prognosis.
Evaluation of the antigen in CTCs
Molecular analysis of isolated CTC
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
1) patients with pathologically proven non-small cell lung cancer
2) age >= 20 years
3) signed informed consent
Key exclusion criteria
None
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Takahashi |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
4110942
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
+81-55-989-5222
t.takahashi@scchr.jp
Public contact
Name of contact person
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Kenmotsu |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
4110942
Address
1007 Shimonagakubo Nagaizumi-cho Sunto-gun,Shizuoka, Japan, 411-8777
TEL
+81-55-989-5222
Homepage URL
h.kenmotsu@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Cancer Center IRB
Address
1007 Shimonagakubo, Nagaizumi-cho
Tel
+81-55-989-5222
h.kikuchi@scchr.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
静岡県立静岡がんセンター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2013 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Treatment and efficacy
Survival
Management information
Registered date
| 2013 | Year | 12 | Month | 04 | Day |
Last modified on
| 2019 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014536
