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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002193
Receipt No. R000002692
Scientific Title The study to evaluate the efficacy and resistance for EGFR-TKIs treatment in lung cancer patients.
Date of disclosure of the study information 2009/07/14
Last modified on 2011/08/15

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Basic information
Public title The study to evaluate the efficacy and resistance for EGFR-TKIs treatment in lung cancer patients.
Acronym The study to evaluate the efficacy and resistance for EGFR-TKIs treatment in lung cancer patients.
Scientific Title The study to evaluate the efficacy and resistance for EGFR-TKIs treatment in lung cancer patients.
Scientific Title:Acronym The study to evaluate the efficacy and resistance for EGFR-TKIs treatment in lung cancer patients.
Region
Japan

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

Objectives
Narrative objectives1 We plan this study to investigate the efficacy and resistance for EGFR-TKIs treatment. We mesure EGFR mutations, MET amplification and the other genomic profiles using the samples obtained from before treatment/ after resistant.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes corrlation of genomic profile and efficacy and resistance
Key secondary outcomes adverse ivent, survival, patinets characteristics

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 EGFR-TKIs, analysis of genomic profiles
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 Lung cancer patients with EGFR-TKIs. All patients give written informed consent.
Key exclusion criteria except for the above-mentioned
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichi Nakamura
Organization Nagasaki-university hospital
Division name second depertment of internal medisine
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization NTOG
Division name Nagasaki-university hospital
Zip code
Address
TEL 095-819-7273
Homepage URL
Email

Sponsor
Institute Second Department of Internal Medicine, Nagasaki University hospital
Institute
Department

Funding Source
Organization None
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
2009 Year 07 Month 14 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 06 Month 17 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2011 Year 08 Month 01 Day
Date of closure to data entry
2011 Year 08 Month 01 Day
Date trial data considered complete
2011 Year 08 Month 01 Day
Date analysis concluded
2011 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 07 Month 13 Day
Last modified on
2011 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002692

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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