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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006762
Receipt No. R000008002
Scientific Title Detection of EGFR and K-ras gene mutations in serum of non-small cell lung cancer patients
Date of disclosure of the study information 2011/11/24
Last modified on 2019/05/31

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Basic information
Public title Detection of EGFR and K-ras gene mutations in serum of non-small cell lung cancer patients
Acronym Detection of EGFR and K-ras gene mutations in serum
Scientific Title Detection of EGFR and K-ras gene mutations in serum of non-small cell lung cancer patients
Scientific Title:Acronym Detection of EGFR and K-ras gene mutations in serum
Region
Japan

Condition
Condition Adenocarcinoma of the lung
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Sensitivity ans specificity of detection with plasma of EGFR and L-ras gene mutation in non-small cell lung cancer
Basic objectives2 Others
Basic objectives -Others Evaluation of relationship between EGFR and K-ras mutation
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Sensitivity and specificity of evaluation of EGFR and K-ras gene mutation with plasma
Key secondary outcomes Correlation between EGFR and K-ras gene mutation evaluated with plasma

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 Treatment-naive patients with lung adenocarcinoma EGFR of which will be tested
Key exclusion criteria Nothing
Target sample size 320

Research contact person
Name of lead principal investigator
1st name Fumio
Middle name
Last name Imamura
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Thoracic Oncology
Zip code 5418567
Address 1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511, Japan
TEL +81-6-6972-1181
Email imamura-fu@mc.pref.osaka.jp

Public contact
Name of contact person
1st name Fumio
Middle name
Last name Imamura
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Thoracic Oncology
Zip code 5418567
Address 1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511, Japan
TEL +81-6-6972-1181
Homepage URL
Email imamura-fu@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
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 Osaka Medical Center for Cancer and Cardiovascular Diseases
Address 1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511, Japan
Tel 0669721181
Email imamura-fu@mc.pref.osaka.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 大阪府立成人病センター、大阪市立総合医療センター、大阪大学医学部

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 288
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
2011 Year 10 Month 21 Day
Date of IRB
2011 Year 10 Month 09 Day
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2019 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Comparison of EGFR adn K-ras gene between plasma and tumors

Management information
Registered date
2011 Year 11 Month 24 Day
Last modified on
2019 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008002

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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