UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of diagnostic tool for skin cancer by the measurement of effective thermal conductivity
Title of the study (Brief title)	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	Taku Fujimura
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Dermatology
Address	Seiryo-machi 1-1, Aoba-ku, Sendai
TEL	022-717-7271
Email	tfujimura1@mac.com

Public contact
Name of contact person	Taku Fujimura
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Dermatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029472