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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015018
Receipt No. R000017469
Scientific Title Analysis of multiplex somatic mutation profile and its prognostic values of non-small cell lung cancer using next generation sequencer (WJOG7914LTR)
Date of disclosure of the study information 2014/09/02
Last modified on 2019/09/06

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Basic information
Public title Analysis of multiplex somatic mutation profile and its prognostic values of non-small cell lung cancer using next generation sequencer (WJOG7914LTR)
Acronym Deep sequencing of lung cancer and prognostic analysis of somatic mutation
Scientific Title Analysis of multiplex somatic mutation profile and its prognostic values of non-small cell lung cancer using next generation sequencer (WJOG7914LTR)
Scientific Title:Acronym Deep sequencing of lung cancer and prognostic analysis of somatic mutation
Region
Japan

Condition
Condition NSCLC
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Archival formalin-fixed, paraffin-embedded specimens were collected from the pts who were enrolled onto WJOG4107 or WJOG6611LTR trials. With the use of next generation sequencer, high-throughput genotyping of somatic hotspot mutations and major variants of ALK, RET and ROS1 fusion genes.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Somatic mutation analysis
Fusion gene analysis
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 Patients enrolled onto WJOG4107 or WJOG6611LTR study who had available DNA/RNA samples
Key exclusion criteria Nothing particular
Target sample size 480

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuto Nishio
Organization Kinki University
Division name Faculty of Medicine, Dept. of Genome Biology
Zip code
Address 377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511
TEL 072-366-0221
Email knishio@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name datacenter
Zip code
Address Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka 556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kinki University Faculty of Medicine, Dept. of Genome Biology
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
2014 Year 09 Month 02 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 322
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 Terminated
Date of protocol fixation
2014 Year 08 Month 10 Day
Date of IRB
2014 Year 10 Month 17 Day
Anticipated trial start date
2014 Year 09 Month 16 Day
Last follow-up date
2019 Year 09 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing particular

Management information
Registered date
2014 Year 09 Month 02 Day
Last modified on
2019 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017469

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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