UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029565
Receipt number R000033780
Scientific Title Immune-related gene signiture profiling in CRC, non-CRC, and lung cancer.
Date of disclosure of the study information 2017/10/15
Last modified on 2022/04/26 16:28:51

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Basic information

Public title

Immune-related gene signiture profiling in CRC, non-CRC, and lung cancer.

Acronym

IOP

Scientific Title

Immune-related gene signiture profiling in CRC, non-CRC, and lung cancer.

Scientific Title:Acronym

IOP

Region

Japan


Condition

Condition

CRC, nonCRC, lung cancer

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Imuune-related gene signiture profiling

Basic objectives2

Others

Basic objectives -Others

the relationship between Imuune-related gene signiture profiling and clinicopathological features, effiicacy of anti-PD-1/PD-L1 and prognosis

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Imuune-related gene signiture profiling

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

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1) cases who were registered in SCRUM-Japan and agreed with secondary use of data and materials

2)cases with enough remaing specimen

Key exclusion criteria

cases who are considered as excluded by the physician

Target sample size

900


Research contact person

Name of lead principal investigator

1st name Takayuki
Middle name
Last name Yoshino

Organization

National Cancer Center Hospital East, Japan

Division name

Department of GI oncology

Zip code

277-8577

Address

6-5-1 Kashiwanoha, Kashiwa-shiChiba-ken, 277-8577 Japan

TEL

04-7133-1111

Email

tyoshino@east.ncc.go.jp


Public contact

Name of contact person

1st name Akihito
Middle name
Last name Kawazoe

Organization

National Cancer Center Hospital East, Japan

Division name

Department of GI oncology

Zip code

277-8577

Address

6-5-1 Kashiwanoha, Kashiwa-shiChiba-ken, 277-8577 Japan

TEL

04-7133-1111

Homepage URL


Email

akawazoe@east.ncc.go.jp


Sponsor or person

Institute

National Cancer Center, Japan

Institute

Department

Personal name



Funding Source

Organization

ONO PHARMACEUTICAL CO., LTD.
Kyowa Hakko Kirin Company, Limited
MSD

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Cancer Center Institutional Review Board

Address

5-1-1, tsukiji, tyuo-ku, Tokyo

Tel

03-3542-2511

Email

NCC_IRBoffice@ml.res.ncc.go.jp


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

2017 Year 10 Month 15 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

651

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

Completed

Date of protocol fixation

2017 Year 09 Month 29 Day

Date of IRB

2017 Year 09 Month 27 Day

Anticipated trial start date

2017 Year 09 Month 29 Day

Last follow-up date

2022 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2017 Year 10 Month 15 Day

Last modified on

2022 Year 04 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033780


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name