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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028616
Receipt No. 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 2019/08/19

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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
Middle name
Last name Takayuki Yoshino
Organization National Cancer Center Hospital East
Division name Department of Gastrointestinal Oncology
Zip code
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
Middle name
Last name Satoshi Yuki
Organization Hokkaido University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
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
Institute National Cancer Center Hospital East
Institute
Department

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
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
2017 Year 09 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
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
2019 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.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


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