UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048426 |
|---|---|
| Receipt number | R000055188 |
| Scientific Title | Usefulness of stratum corneum analysis for malignancy of the melanocyte system. |
| Date of disclosure of the study information | 2022/07/31 |
| Last modified on | 2024/01/22 08:55:39 |
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Basic information
Public title
Usefulness of stratum corneum analysis for malignancy of the melanocyte system.
Acronym
Usefulness of stratum corneum analysis for malignancy of the melanocyte system.
Scientific Title
Usefulness of stratum corneum analysis for malignancy of the melanocyte system.
Scientific Title:Acronym
Usefulness of stratum corneum analysis for malignancy of the melanocyte system.
Region
| Japan |
Condition
Condition
melanoma
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the mechanism of carcinogenesis by ultraviolet radiation of skin primary melanoma occurring in exposed areas by melanin ratio (Eumelanin/Pheomelanin) in epidermal stratum corneum.
Basic objectives2
Others
Basic objectives -Others
This study confirms the correlation between the degree of UV exposure and melanoma development by analyzing the ratio of Eumelanin to Pheomelanin in the perilesional and nonlesional areas of melanoma patients, exposed areas of healthy individuals, and nonexposed epidermal stratum corneum, and further tests whether the ratio of Eumelanin to Pheomelanin can be a predictive indicator for the risk of developing melanoma.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To verify the mechanism of carcinogenesis by ultraviolet radiation of skin primary melanoma occurring in exposed areas by melanin ratio (Eumelanin/Pheomelanin) in epidermal stratum corneum.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with primary cutaneous melanoma for whom surgical treatment is decided
Healthy individuals without melanoma as controls (patients attending a dermatologist clinic).
Key exclusion criteria
Melanoma other than primary skin
Melanoma with cutaneous metastases
Individuals taking or taking topical medications or supplements that affect melanogenesis, such as anti-inflammatory agents, antioxidants, and steroids, within 3 months.
Persons who have experienced contact dermatitis with commercial household cellophane tape
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Yamamoto |
Organization
Wakayama Medical University
Division name
Department of Dermatology
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
TEL
073-441-0661
yukiy@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Matsunaka |
Organization
TOKIWA Pharmaceutical Co., Ltd.
Division name
NOV Academic Research
Zip code
1070062
Address
1-2-6 Minami-aoyama Minato-ku
TEL
08024879141
Homepage URL
yumi_murakami@n1.noevir.co.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
NOV Academic Research
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
Research Ethics Committee of Wakayama Medical University.
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.ac.jp
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
| 2022 | Year | 07 | Month | 31 | 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
41
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A Prospective Case-Control (Case-Control) Study for Designated Illness Patients and Healthy Individuals by Multicenter.
Management information
Registered date
| 2022 | Year | 07 | Month | 21 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055188
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
