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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032692
Receipt No. R000037282
Scientific Title Development of CTCs detection and evaluation in lung cancer patients using On-chip Sort
Date of disclosure of the study information 2018/06/01
Last modified on 2019/11/25

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Basic information
Public title Development of CTCs detection and evaluation in lung cancer patients using On-chip Sort
Acronym CTCs detection using On-chip Sort
Scientific Title Development of CTCs detection and evaluation in lung cancer patients using On-chip Sort
Scientific Title:Acronym CTCs detection using On-chip Sort
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Feasibility study of CTCs detection and evaluation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Establishment of CTCs detection and evaluation
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 Patients who are diagnosed lung cancer and fit to provide blood samples.

Patients who provide the written informed consent.
Key exclusion criteria Patients regarded unfit by the physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yasuhiro
Middle name
Last name Koh
Organization Wakayama Medical University
Division name Third Department of Internal Medicine
Zip code 641-8509
Address 8-1-1 Kimiidera, Wakayama
TEL 073-441-0619
Email ykoh@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Koh
Middle name
Last name Yasuhiro
Organization Wakayama Medical University
Division name Third Department of Internal Medicine
Zip code 641-8509
Address 8-1-1 Kimiidera, Wakayama
TEL 073-441-0619
Homepage URL
Email ykoh@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
On-chip Biotechnologies
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 Wakayama Medical University
Address 8-1-1 Kimiidera, Wakayama
Tel 073-441-0896
Email wa-rinri@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 06 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 07 Day
Date of IRB
2018 Year 06 Month 05 Day
Anticipated trial start date
2018 Year 06 Month 05 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 Samples will be analyzed at Sumika Chemical Analysis Service Ltd.

Management information
Registered date
2018 Year 05 Month 23 Day
Last modified on
2019 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037282

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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