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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014782
Receipt No. R000017177
Scientific Title Clinical applications of next generation sequencing on therapeutic decision-making in lung cancer
Date of disclosure of the study information 2014/08/10
Last modified on 2014/08/06

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Basic information
Public title Clinical applications of next generation sequencing on therapeutic decision-making in lung cancer
Acronym Clinical applications of next generation sequencing on therapeutic decision-making in lung cancer
Scientific Title Clinical applications of next generation sequencing on therapeutic decision-making in lung cancer
Scientific Title:Acronym Clinical applications of next generation sequencing on therapeutic decision-making in lung cancer
Region
Japan

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

Objectives
Narrative objectives1 To detect actionable alterations leading to clinical benefit of targeted therapies in lung cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We assessed the percentage of patients with additional therapy options uncovered by detecting potentially actionable genetic alterations.
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 (i) Histologically confirmed diagnosis of lung cancer
(ii) patient provided written informed consent to conduct genomic studies in accordance with the Institutional Review Board of Kinki University.
Key exclusion criteria None
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nakagawa Kazuhiko
Organization Kinki University
Division name Medical oncology
Zip code
Address 377-2 Ohno-higashi, Osaka-Sayama
TEL 072-366-0221
Email nakagawa@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeda Masayuki
Organization Kinki University
Division name Medical oncology
Zip code
Address 377-2 Ohno-higashi, Osaka-Sayama
TEL 072-366-0221
Homepage URL
Email takedamasa2004@yahoo.co.jp

Sponsor
Institute Kinki University
Institute
Department

Funding Source
Organization Kinki University
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

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 10 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 Open public recruiting
Date of protocol fixation
2013 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The percentage of patients with additional therapy options uncovered by detecting potentially actionable genetic alterations, and who actually received genotype-directed therapy based on their genetic testing results, and the success rate of the assay was caluculated, if target sample was enrolled.

Management information
Registered date
2014 Year 08 Month 06 Day
Last modified on
2014 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017177

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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