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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011257
Receipt No. 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 2013/07/23

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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
Last 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
Email

Public contact
1st 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
Email

Sponsor
Institute Kinki University Faculty of Medicine
Institute
Department

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
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
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 Open public recruiting
Date of protocol fixation
2013 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
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
2013 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013193

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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