UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025618 |
|---|---|
| Receipt number | 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 10:17:11 |
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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
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
tfujimura1@mac.com
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029472
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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