UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015018 |
|---|---|
| Receipt number | 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 09:13:04 |
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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
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
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017469
