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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043800
Receipt No. R000049996
Scientific Title The exploratory study to evaluate the association between efficacy of bevacizumab combination therapy and pretreatment plasma vascular endothelial growth factor-D levels in metastatic colorectal cancer (GI-SCREEN-CRC-Ukit additional study 01)
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/31

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Basic information
Public title The exploratory study to evaluate the association between efficacy of bevacizumab combination therapy and pretreatment plasma vascular endothelial growth factor-D levels in metastatic colorectal cancer (GI-SCREEN-CRC-Ukit additional study 01)
Acronym GI-SCREEN-CRC-Ukit additional study 01
Scientific Title The exploratory study to evaluate the association between efficacy of bevacizumab combination therapy and pretreatment plasma vascular endothelial growth factor-D levels in metastatic colorectal cancer (GI-SCREEN-CRC-Ukit additional study 01)
Scientific Title:Acronym GI-SCREEN-CRC-Ukit additional study 01
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To measure plasma VEGF-D levels in patients with colorectal cancer using Corgenix's VEGF-D ELISA kit and to evaluate its association with the efficacy of bevacizumab combination therapy.
Basic objectives2 Others
Basic objectives -Others Correlation between VEGF-D measurements and efficacy (response rate, progression-free survival, and overall survival)
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the association between plasma VEGF-D levels and the efficacy of bevacizumab combination therapy in patients with 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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients enrolled in the GI-SCREEN CRC-Ukit study (UMIN000028616) who have consented to the secondary use of plasma samples and have not withdrawn their consent.
2) Patients are enrolled in (1), (2), and (5) of the following five cohorts
(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)
3) There are residual samples available for VEGF-D testing.
Key exclusion criteria 1) Unsuitable for the study according to the opinion of the investigators
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Hiroya
Middle name
Last name Taniguchi
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, 277-8577, Japan
TEL 04-7133-1111
Email hirtanig@east.ncc.go.jp

Public contact
Name of contact person
1st name Hiroya
Middle name
Last name Taniguchi
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, 277-8577, Japan
TEL 04-7133-1111
Homepage URL
Email hirtanig@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Chugai Pharma
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, 277-8577, Japan
Tel 04-7133-1111
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
2021 Year 04 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 11 Month 01 Day
Date of IRB
2021 Year 03 Month 19 Day
Anticipated trial start date
2021 Year 04 Month 15 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2021 Year 03 Month 31 Day
Last modified on
2021 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049996

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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