UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023259
Receipt number 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 20:16:30

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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 or person

Institute

National Cancer Center

Institute

Department

Personal name



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

Value
https://center6.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