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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025618
Receipt No. R000029472
Scientific Title Clinical study of diagnostic tool for skin cancer by the measurement of effective thermal conductivity
Date of disclosure of the study information 2017/01/11
Last modified on 2019/01/13

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Basic information
Public title Clinical study of diagnostic tool for skin cancer by the measurement of effective thermal conductivity
Acronym Clinical study of diagnostic tool for skin cancer
Scientific Title Clinical study of diagnostic tool for skin cancer by the measurement of effective thermal conductivity
Scientific Title:Acronym Clinical study of diagnostic tool for skin cancer
Region
Japan

Condition
Condition melanoma, non-melanoma skin cancer, benign skin tumor
Classification by specialty
Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of Skin Structure and Temperature Distribution in Body on Non-invasive Measurement of Effective Thermal Conductivity of skin tumor.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Diagnostic accuracy of the thermistor probe utilizing guard heater for melanoma.
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 Patients who agree this clinical trial in writing.

The patients who are older than twenty years old.

The patients who are diagnosed as skin cancer by dermatologist in department of dermatology, tohoku university graduate school of medicine.

The patients whose tomor possesses normal skin in adjacent to tumor mass.

The patients who agree with the surgical operation or biopsy of tumor.
Key exclusion criteria 1) The patients who cannot perform biopsy or surgical therapy.
2) The tumor with ulceration.
3) The patients who is not suitable for the administration of skin biopsy, decided by doctor.
4) The patients who is not suitable for this clinical study, decided by doctor.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taku Fujimura
Organization Tohoku University Graduate School of Medicine
Division name Department of Dermatology
Zip code
Address Seiryo-machi 1-1, Aoba-ku, Sendai
TEL 022-717-7271
Email tfujimura1@mac.com

Public contact
Name of contact person
1st name
Middle name
Last name Taku Fujimura
Organization Tohoku University Graduate School of Medicine
Division name Department of Dermatology
Zip code
Address Seiryo-machi 1-1, Aoba-ku, Sendai
TEL 022-717-7271
Homepage URL
Email tfujimura1@mac.com

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2017 Year 01 Month 11 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
2016 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 20 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information Open public recruiting

Management information
Registered date
2017 Year 01 Month 11 Day
Last modified on
2019 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029472

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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