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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002911
Receipt No. R000003216
Scientific Title Clinical Significance of Circulating Tumor Cells in Completely Resected Non-Small Cell Lung Cancer
Date of disclosure of the study information 2010/01/15
Last modified on 2009/11/30

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Basic information
Public title Clinical Significance of Circulating Tumor Cells in Completely Resected Non-Small Cell Lung Cancer
Acronym Clinical Significance of Circulating Tumor Cells in Completely Resected Non-Small Cell Lung Cancer
Scientific Title Clinical Significance of Circulating Tumor Cells in Completely Resected Non-Small Cell Lung Cancer
Scientific Title:Acronym Clinical Significance of Circulating Tumor Cells in Completely Resected Non-Small Cell Lung Cancer
Region
Japan

Condition
Condition non-samll cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate relation ships between the change in number of circulating tumor cells in peripheral blood or the number of circulating tumor cells in pulmonary vein and incidence of recurrent disease or prognosis.
Basic objectives2 Others
Basic objectives -Others Prognostic Significance
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To elucidate the rlationship between peri/pv CTC and OS(over all survival)/DFS(disease free survival).
Key secondary outcomes To evaluate the influence of surgical procedure on the number of CTC.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 blood sampling from peripheral vein/intraoperative blood sampling from drainage pulmonary vein
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.Diagnosed as NSCLC by histology/cytology(except low grade malignancy such as Carcinoid, Adenoidcystic carcinoma, Mucoepidermoid Carcinoma
2.cStage I or II
3.at least lobectomy will be performed
4. ECOG PS 0-1
5. Written informed consent
Key exclusion criteria 1.Double cancer:simaltaneous or sequential with more than 5 years disease interval.
2.sevior complication of major organ
3.pregnant or having intention to have child or giving the breast feeding
4.sever alergy against paticular drug
5.mental disorder
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Date Hiroshi
Organization Kyoto University Hospital
Division name Respiratory Surgery
Zip code
Address 54 Kawaharacho Shougoin Sakyo Kyoto
TEL 075-751-4975
Email

Public contact
Name of contact person
1st name
Middle name
Last name Miyahara Ryo
Organization Kyoto University Hospital
Division name Respiratory Surgery
Zip code
Address
TEL
Homepage URL
Email rmiyahar@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Respiratory Surgery
Kyoto University Hospital
Institute
Department

Funding Source
Organization Department of Respiratory Surgery
Kyoto University Hospital
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
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

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 15 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 Preinitiation
Date of protocol fixation
2009 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2017 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 12 Month 16 Day
Last modified on
2009 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003216

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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