UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041894 |
|---|---|
| Receipt number | R000047816 |
| Scientific Title | Stability testing of angiogenesis-related factors in the Ukit test |
| Date of disclosure of the study information | 2020/09/25 |
| Last modified on | 2020/09/25 16:45:27 |
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Basic information
Public title
Stability testing of angiogenesis-related factors in the Ukit test
Acronym
Stability testing of angiogenesis-related factors in the Ukit test
Scientific Title
Stability testing of angiogenesis-related factors in the Ukit test
Scientific Title:Acronym
Stability testing of angiogenesis-related factors in the Ukit test
Region
| Japan |
Condition
Condition
gastrointestinal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence of storage time in Ukit test.
Basic objectives2
Others
Basic objectives -Others
Stability of measured values in Ukit test
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Consistency of measurements of VEGF-A and VEGF-D immediately after blood collection and after a certain time
Key secondary outcomes
Evaluation of the consistency of measurements of factors involved in angiogenesis other than VEGF-A and VEGF-D immediately after blood sampling and after a certain period of time, he relationship between angiogenic factors and clinical information
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) Pathologically proven gastrointestinal cancer.
2) Has been scheduled or is receiving palliative chemotherapy.
3) 20 years of age or older.
4) PS (ECOG) score of 0-2.
5) Patient is attending/hospitalized at the National Cancer Center Hospital.
6) Have received written consent for this study from the patient.
Key exclusion criteria
None.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Atsuo |
| Middle name | |
| Last name | Takashima |
Organization
National Cancer Center Hospital
Division name
Department of Gastrointestinal Medical Oncology
Zip code
104-0045
Address
1-1, 5, Tsukiji, chuo, tokyo, 104-0045, Japan
TEL
03-3542-2511
atakashi@ncc.go.jp
Public contact
Name of contact person
| 1st name | Toshiharu |
| Middle name | |
| Last name | Hirose |
Organization
National Cancer Center Hospital
Division name
Department of Gastrointestinal Medical Oncology
Zip code
104-0045
Address
1-1, 5, Tsukiji, chuo, tokyo, 104-0045, Japan
TEL
03-3542-2511
Homepage URL
toshiros@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
G&G Science Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
National Cancer Center Hospital Certified Review Board
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan 104-0045
Tel
03-3542-2511
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
国立がん研究センター中央病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 25 | 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 | 09 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Stability testing of angiogenesis-related factors in the Ukit test
Management information
Registered date
| 2020 | Year | 09 | Month | 25 | Day |
Last modified on
| 2020 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047816
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
