UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028616
Receipt number R000032751
Scientific Title The multicenter study to examine angiogenesis-related factors in advanced colorectal cancer
Date of disclosure of the study information 2017/09/21
Last modified on 2023/08/16 20:33:34

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Basic information

Public title

The multicenter study to examine angiogenesis-related factors in advanced colorectal cancer

Acronym

GI-SCREEN CRC-Ukit

Scientific Title

The multicenter study to examine angiogenesis-related factors in advanced colorectal cancer

Scientific Title:Acronym

GI-SCREEN CRC-Ukit

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Relationship between angiogenesis-related factors and therapeutic effects in advanced colorectal cancer

Basic objectives2

Others

Basic objectives -Others

Association between pre-treatment angiogenesis-related factors and clinicopathological features
Fluctuant of factors angiogenesis-related factors pre- and post chemotherapy

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relationship between angiogenesis-related factors and therapeutic effects in advanced colorectal cancer

Key secondary outcomes

Association between pre-treatment angiogenesis-related factors and clinicopathological features
Fluctuant of factors angiogenesis-related factors pre- and post chemotherapy


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

1)Patients with pathologically or histologically confirmed colorectal cancer
2)Patient with indication of chemotherapy with unresectable metastasis or recurrent disease
3)Confirmed RAS mutational status
4)Meet the following (1) or (2)
(1)Patients who have not administerd chemotherapy for metastatic disease
(2)Patients immediately after completion of chemotherapy plus bevacizumab or chemothrapy plus anti-EGFR antibody for the first line treatment for metastatic disease
5)Patient who is planned to receive following (1) to (5) after registration
(1)chemotherapy plus bevacizumab (first line)
(2)chemotherapy plus anti-EGFR antibody (first line)
(3)FOLFIRI plus ramucirumab (second line)
(4)FOLFIRI plus aflibercept (second line)
(5)chemotherapy plus bevacizumab (second line)
6)Age 20 years or above
7)Written informed consent was obtained

Key exclusion criteria

1)Judged by the investigator to be inappropriate for study participation for any reason

Target sample size

500


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 Gastrointestinal Oncology

Zip code

277-8577

Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

TEL

04-7133-1111

Email

tyoshino@east.ncc.go.jp


Public contact

Name of contact person

1st name Satoshi
Middle name
Last name Yuki

Organization

Hokkaido University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code

060-8648

Address

Kita-15, Nishi-7, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan

TEL

011-706-5657

Homepage URL


Email

satoshi-yuuki175@joy.ocn.ne.jp


Sponsor or person

Institute

National Cancer Center Hospital East

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Develop,ent

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor

G&G Science Co., Ltd

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical Research and Medical Innovation Center, Hokkaido University Hospital

Address

Kita-15, Nishi-7, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan

Tel

011-706-7413

Email

REG_DC@pop.med.hokudai.ac.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 09 Month 21 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

498

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Paper not accepted

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 08 Month 09 Day

Date of IRB

2017 Year 12 Month 12 Day

Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date

2021 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study Design: Observational study
Target population:the patients who visit the research implementation facility until September 30 2020 from research permit date and meet the selection criteria

If the patient is participating in GI-SCREEN 2013-01-CRC (UMIN000016343)/GI-SCREEN CRC-MSI(UMIN000020437), we investigate the association between results of both analysis data.


Management information

Registered date

2017 Year 08 Month 09 Day

Last modified on

2023 Year 08 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032751


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name