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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023259
Receipt No. R000026802
Scientific Title Study of tenetic profiling and immune response of thoracic and solid cancers using clinical specimens
Date of disclosure of the study information 2016/07/21
Last modified on 2016/07/20

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Basic information
Public title Study of tenetic profiling and immune response of thoracic and solid cancers using clinical specimens
Acronym Genetic profiling and immune response of thoracic and solid cancers
Scientific Title Study of tenetic profiling and immune response of thoracic and solid cancers using clinical specimens
Scientific Title:Acronym Genetic profiling and immune response of thoracic and solid cancers
Region
Japan

Condition
Condition Solid cancer
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 By analyzing genetic expression and immune profiling of clinical specimens from patients with thoracic and other solid tumor who are planned for or treated with anti-cancer treatment, changes related to efficacy or safety will be evaluated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Response to treatment by RECIST
Key secondary outcomes Safety (evaluated by CTCAE)

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are treated by any anti-cancer therapy in our institution.
Patients who have at leas one specimen to analyze
Patients who agreed to this study
Key exclusion criteria none
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Goto
Organization National Cancer Center Hospital
Division name Thoracic Oncology
Zip code
Address 5-1-1 Tsukiji Chuoku Tokyo
TEL 03-3542-2511
Email ygoto@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Goto
Organization National Cancer Center Hospital
Division name Thoracic Oncology
Zip code
Address 5-1-1 Tsukiji Chuoku Tokyo
TEL 03-3542-2511
Homepage URL
Email ygoto@ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization National Cancer Center
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
2016 Year 07 Month 21 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
2015 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observing clinical course and related factors.

Management information
Registered date
2016 Year 07 Month 20 Day
Last modified on
2016 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026802

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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