UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043800 |
|---|---|
| Receipt number | 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 | 2023/01/10 20:27:05 |
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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
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
hirtanig@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049996
