UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008716
Receipt number R000010241
Scientific Title Expression of S100 protein family in skin tumors
Date of disclosure of the study information 2012/08/17
Last modified on 2014/03/30 01:17:09

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Basic information

Public title

Expression of S100 protein family in skin tumors

Acronym

S100 protein family in skin tumors

Scientific Title

Expression of S100 protein family in skin tumors

Scientific Title:Acronym

S100 protein family in skin tumors

Region

Japan


Condition

Condition

Malignant melanoma, Nevus pigmentosus, squamous cell carcinoma,basal cell carcinoma, adnexal tumor, Bowen disease and so on.

Classification by specialty

Dermatology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate a role of S100 protein in melanoma.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of expression and amount of S100 protein in various types of skin tumor and their serum.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Maneuver Other

Interventions/Control_1

Blood sampling

Interventions/Control_2

Excision

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

Malignant melanoma
Nevus pigmentosus
Squamous cell carcinoma
Basal cell carcinoma
Adnexal tumor
Bowen's disease

Key exclusion criteria

n.p.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Fujita

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Environmental Immuno-Dermatology

Zip code


Address

3-9,Fukuura,Kanazawa,Yokohama,236-0004, JAPAN

TEL

045-787-2675

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Environmental Immuno-Dermatology

Zip code


Address

Fukuura3-9, Kanazawa, Yokohama

TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Environmental Immuno-Dermatology, Yokohama City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Scholarship donations
Basic research funding

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

2012 Year 08 Month 17 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

Terminated

Date of protocol fixation

2012 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 08 Month 01 Day

Last follow-up date

2014 Year 03 Month 28 Day

Date of closure to data entry

2014 Year 03 Month 28 Day

Date trial data considered complete

2014 Year 03 Month 28 Day

Date analysis concluded

2014 Year 03 Month 28 Day


Other

Other related information



Management information

Registered date

2012 Year 08 Month 17 Day

Last modified on

2014 Year 03 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010241


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name