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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000012488
Receipt No. 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

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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
Email 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
Email h.kenmotsu@scchr.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014536

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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