UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011257 |
|---|---|
| Receipt number | R000013193 |
| Scientific Title | Determination of VEGF level in skin tissue from patients with solid tumor and healthy volunteers |
| Date of disclosure of the study information | 2013/07/23 |
| Last modified on | 2020/09/17 16:41:31 |
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Basic information
Public title
Determination of VEGF level in skin tissue from patients with solid tumor and healthy volunteers
Acronym
DERMASKREEN
Scientific Title
Determination of VEGF level in skin tissue from patients with solid tumor and healthy volunteers
Scientific Title:Acronym
DERMASKREEN
Region
| Japan |
Condition
Condition
inoperable colorectal cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish the method to determine VEGFA levels in epidermal cells obtained via scoth-tape
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine VEGF levels in epidermal cells
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
untreated patients with inoperable colorectal cancer
Key exclusion criteria
those wiht active infection with HBV or HCV
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Nakagawa |
Organization
Kinki University Faculty of Medicine
Division name
Division of Medical Oncology
Zip code
Address
377-2 Ohnohigashi, Osakasayama, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kinki University Faculty of Medicine
Division name
Division of Medical Oncology
Zip code
Address
377-2 Ohnohigashi, Osakasayama, Ohnodai
TEL
Homepage URL
Sponsor or person
Institute
Kinki University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
SHISEIDO
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
Address
Tel
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
| 2013 | Year | 07 | Month | 23 | 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
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To determine VEGF levels in epidermal cells obtained from patients with inoperable colorectal cancer or healthy volunteers
Management information
Registered date
| 2013 | Year | 07 | Month | 23 | Day |
Last modified on
| 2020 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013193
