UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026396 |
|---|---|
| Receipt number | R000030327 |
| Scientific Title | Novel diagnostic method for malignant melanoma using fluorescence in situ hybridization (FISH) method |
| Date of disclosure of the study information | 2017/03/04 |
| Last modified on | 2017/03/12 14:26:01 |
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Basic information
Public title
Novel diagnostic method for malignant melanoma using fluorescence in situ hybridization (FISH) method
Acronym
Diagnosis of Malignant Melanoma by FISH
Scientific Title
Novel diagnostic method for malignant melanoma using fluorescence in situ hybridization (FISH) method
Scientific Title:Acronym
Diagnosis of Malignant Melanoma by FISH
Region
| Japan |
Condition
Condition
malignant melanoma
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Regarding malignant melanoma, there are some cases that are difficult to diagnose in the histopathological diagnosis and immunohistochemical diagnosis. Therefore, we aim to improve diagnostic accuracy by introducing molecular genetic techniques. Specifically, diagnosis of malignant melanoma was carried out using fluorescence in situ hybridization (FISH) method for three regions (6p25, 6q23, 11q13) by auxiliary diagnosis. It is thought that clear identification early diagnosis of malignant melanoma or pigmented nevus, and leading to appropriate treatment.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Presence or absence of signal detection by fluorescence in situ hybridization (FISH) method for three regions (6p25, 6q23, 11q13) in lesions suspected of malignant melanoma
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
A skin biopsy is performed on a skin lesion suspected of malignant melanoma and a specimen for carrying out the FISH method is prepared from the harvested tissue.
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
1) Patients with skin lesions suspected of malignant melanoma
2) over 20 years old
3) patients who obtain document consent by free will
Key exclusion criteria
1) Patients who can not perform skin biopsy
2) Patients who are judged inappropriate for this trial by their attending physician
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironobu Ihn |
Organization
Kumamoto University
Division name
Department of Dermatology and Plastic Surgery, Faculty of Life Sciences
Zip code
Address
1-1-1 Honjo Chuo-ku Kumamoto, Japan
TEL
096-373-5233
ihn-der@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Aoi |
Organization
Kumamoto University
Division name
Department of Dermatology and Plastic Surgery, Faculty of Life Sciences
Zip code
Address
1-1-1 Honjo Chuo-ku Kumamoto, Japan
TEL
096-373-5233
Homepage URL
junjunaoi@gmail.com
Sponsor or person
Institute
Department of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University Hospital
Organization
Division
Category of Funding Organization
Other
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
熊本大学医学部附属病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 04 | Day |
Last modified on
| 2017 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030327
