UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of tenetic profiling and immune response of thoracic and solid cancers using clinical specimens
Title of the study (Brief title)	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)

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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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yasushi Goto
Organization	National Cancer Center Hospital
Division name	Thoracic Oncology
Address	5-1-1 Tsukiji Chuoku Tokyo
TEL	03-3542-2511
Email	ygoto@ncc.go.jp

Public contact
Name of contact person	Yasushi Goto
Organization	National Cancer Center Hospital
Division name	Thoracic Oncology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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