UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043516
Receipt number R000049590
Scientific Title The clinical study to investigate between immune and gene-expression profile and clinical significance
Date of disclosure of the study information 2021/03/15
Last modified on 2022/03/03 15:24:04

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Basic information

Public title

The clinical study to investigate between immune and gene-expression profile and clinical significance

Acronym

GENOIMMUNE-CRC

Scientific Title

The clinical study to investigate between immune and gene-expression profile and clinical significance

Scientific Title:Acronym

GENOIMMUNE-CRC

Region

Japan


Condition

Condition

colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery Adult

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

We clarify the clinical significance of immune status and gene-expression profile by comprehensive analyses. Through the analyses, we investigate the new treatment strategy.

Basic objectives2

Others

Basic objectives -Others

Biomarker study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The clinical significance of immune and gene-expression profile in colorectal cancer

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with colorectal cancer whose tumor specimens and blood samples were collected in both clinical practice and clinical trial

Key exclusion criteria

None

Target sample size

338


Research contact person

Name of lead principal investigator

1st name Takayuki
Middle name
Last name Yoshino

Organization

National Cancer Center Hospital East

Division name

Department of Gastroenterology and Gastrointestinal Oncology

Zip code

277-8577

Address

6-5-1, Kashiwanoha, Kashiwa, Chiba

TEL

04-7133-1111

Email

tyoshino@east.ncc.go.jp


Public contact

Name of contact person

1st name Hideaki
Middle name
Last name Bando

Organization

Aichi Cancer Center

Division name

Department of Clinical Oncology

Zip code

464-8681

Address

1-1, Kanokoden, Chikusa-ku, Nagoya, Aichi

TEL

052-762-6111

Homepage URL


Email

hbando@aichi-cc.jp


Sponsor or person

Institute

National Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

Ono pharmaceutical

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

6-5-1, Kashiwanoha, Kashiwa, Chiba

Tel

04-7133-1111

Email

irst@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

2021 Year 03 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


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

2020 Year 10 Month 27 Day

Date of IRB

2020 Year 11 Month 24 Day

Anticipated trial start date

2021 Year 03 Month 15 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We investigate the change of immune and gene-expression profiles between pre and post chemotherapy, radiotherapy, and immune-checkpoint inhibitor.Additionally, we investigate the correlations between change of immune and gene-expression profiles and efficacies of immune-checkpoint inhibitor.


Management information

Registered date

2021 Year 03 Month 03 Day

Last modified on

2022 Year 03 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049590


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name