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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001896
Receipt No. R000002292
Scientific Title The clinical significance of circulating tumor cell in metastatic Non-Small Cell Lung Cancer
Date of disclosure of the study information 2009/04/18
Last modified on 2013/03/05

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Basic information
Public title The clinical significance of circulating tumor cell in metastatic Non-Small Cell Lung Cancer
Acronym Circulating Tumor Cell in Non-Small Cell Lung Cancer
Scientific Title The clinical significance of circulating tumor cell in metastatic Non-Small Cell Lung Cancer
Scientific Title:Acronym Circulating Tumor Cell in Non-Small Cell Lung Cancer
Region
Japan

Condition
Condition metastatic non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the change of CTC between before and after chemotherapy and radiographic response.

To compare the change of CTC between before and after chemotherapy and progression-free survival or overall survival.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To clarify the relation between CTC and tumor response.
Key secondary outcomes To clarify the relation between CTC and progression-free survival or overall survival.

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) histologically or cytologically confirmed non-small cell lung cancer
2) metastatic disease
3) chemotherapy is scheduled
4) any prior treatment is permitted
5) more than 2 weeks since last administration of chemotherapy
6) measurable disease
7) age: over 20
8) life expectancy: more than 3 months
9) written informed consent
Key exclusion criteria 1) chemotherapy including amurubicin
2) Uncontrolled pleural effusion
3) symptomatic brain metastases
4) active concomitant malignancy
5) serious concurrent illness, such as hypertension, angina pectoris, myocardial infarction, or severe infection
6) pregnant/lactating women
7) history of severe drug allergy
8) psychiatric disease
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Young Hak Kim
Organization Graduate School of Medicine, Kyoto University
Division name Department of Respiratory Medicine
Zip code
Address 54 Shogoin-Kawaharacho, Sakyo-Ku, Kyoto 606-8507, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Young Hak Kim
Organization Graduate School of Medicine, Kyoto University
Division name Department of Respiratory Medicine
Zip code
Address
TEL 075-751-3830
Homepage URL
Email

Sponsor
Institute Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization Ortho-Clinical Diagnostics K.K.
Organization
Division
Category of Funding Organization Profit organization
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
2009 Year 04 Month 18 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 Completed
Date of protocol fixation
2009 Year 04 Month 14 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2012 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective observation study

Management information
Registered date
2009 Year 04 Month 18 Day
Last modified on
2013 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002292

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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