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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005037
Receipt No. R000005990
Scientific Title Clinical Significance of Circulating Tumor Cells in in-operable Lung Cancer
Date of disclosure of the study information 2011/02/06
Last modified on 2014/05/21

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Basic information
Public title Clinical Significance of Circulating Tumor Cells in in-operable Lung Cancer
Acronym Clinical Significance of Circulating Tumor Cells in in-operable Lung Cancer
Scientific Title Clinical Significance of Circulating Tumor Cells in in-operable Lung Cancer
Scientific Title:Acronym Clinical Significance of Circulating Tumor Cells in in-operable Lung Cancer
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate relation ships between the change in number of circulating tumor cells in peripheral blood and incidence of recurrent disease or prognosis.
Basic objectives2 Others
Basic objectives -Others To evaluate relation ships between the change in number of circulating tumor cells in peripheral blood and incidence of recurrent disease or prognosis.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To elucidate the rlationship between CTC and OS(over all survival).
Key secondary outcomes To elucidate the rlationship between CTC and DFS (disease free survival), tumor response and recurrence site.

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 1.Diagnosed as lung cancer by histology/cytology
2.No prior treatment
3.In-operable
4. Measureable disease
5. Written informed consent
Key exclusion criteria 1.Double cancer
2.sevior complication of major organ
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohisa Yoshizawa
Organization Niigata University Medical and Dental Hospital
Division name Bioscience Medical Research Center
Zip code
Address 1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL 025-227-2517
Email hy0522@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirohisa Yoshizawa
Organization Niigata University Medical and Dental Hospital
Division name Bioscience Medical Research Center
Zip code
Address 1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL 025-227-2517
Homepage URL
Email hy0522@med.niigata-u.ac.jp

Sponsor
Institute Niigata Lung Cancer Treatment Group
Institute
Department

Funding Source
Organization Niigata Foundation of the Promotion of Medicine
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 新潟肺癌治療研究会参加施設

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 06 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 Completed
Date of protocol fixation
2010 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2012 Year 02 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 03 Month 01 Day
Date analysis concluded
2012 Year 05 Month 01 Day

Other
Other related information To elucidate whether CTC of pre and post standard tratment could be a prognostic factor of lung cancer.

Management information
Registered date
2011 Year 02 Month 06 Day
Last modified on
2014 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005990

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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