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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003179
Receipt No. R000003277
Scientific Title Research for order-made medicine based on molecular analysis of genetic aberrations in lung cancer
Date of disclosure of the study information 2010/03/01
Last modified on 2014/10/27

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Basic information
Public title Research for order-made medicine based on molecular analysis of genetic aberrations in lung cancer
Acronym Research for order-made medicine based on molecular analysis of genetic aberrations in lung cancer
Scientific Title Research for order-made medicine based on molecular analysis of genetic aberrations in lung cancer
Scientific Title:Acronym Research for order-made medicine based on molecular analysis of genetic aberrations in lung cancer
Region
Japan

Condition
Condition primary lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 to detect gene and gene aberrations associated with malignancy, prognosis and treatment response by analysis of correlation between genetic aberrations and clinicopathological factors
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes orrelation between genetic aberrations and clinicopathological factors
Key secondary outcomes

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 Provision of informed consent and availability of clinical specimens for analysis of lung cancer-related genes.
Key exclusion criteria Lack of provision of informed consent.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhiko Nakamura
Organization St. Marianna University School of Medicine
Division name Department of Chest Surgery
Zip code
Address Sugao 2-16-1, Miyamae-ku, Kanagawa Kawasaki, Japan
TEL 044-977-8111
Email h-nakamura@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuo Shimmyo
Organization St. Marianna University School of Medicine
Division name Department of Chest Surgery
Zip code
Address Sugao-2-16-1, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL 044-977-8111
Homepage URL
Email t2shinmyo@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine, Department of Chest Surgery
Institute
Department

Funding Source
Organization St. Marianna University School of Medicine, Department of Chest Surgery
Organization
Division
Category of Funding Organization Other
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 聖マリアンナ医科大学 (St. Marianna University School of Medicine)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 01 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
We have taken lung samples in 76 cases up to now, which include resected tissue of lung carcinomas about 1g each cases, and cell stamped slide glasses in the -40 degrees freezer. And we succeed in extraction DNA from these 10 cases, and analyzed the EGFR hotspot mutation L858R in exon 21 and in-frame deletion of exon 19 that account for approximately 91% of EGFR kinase domain mutations by LH-MSA(Loop Hybrid-Mobility shift assay) after polymerase chain reaction (PCR).  In addition, FISH(fluorescence in situ hybridization) and immunohistochemistory stein using EGFR specific antigen was performed, resulted in detection of EGFR mutation in 4 cases. Further sample collection and analyses will be planned.  
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 Enrolling by invitation
Date of protocol fixation
2009 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Taking samples and registration In progress

Management information
Registered date
2010 Year 02 Month 14 Day
Last modified on
2014 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003277

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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