UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026313 |
|---|---|
| Receipt number | R000030220 |
| Scientific Title | A clinical study on conjunctival malignant melanoma |
| Date of disclosure of the study information | 2017/03/31 |
| Last modified on | 2018/02/27 13:51:46 |
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Basic information
Public title
A clinical study on conjunctival malignant melanoma
Acronym
A clinical study on conjunctival malignant melanoma
Scientific Title
A clinical study on conjunctival malignant melanoma
Scientific Title:Acronym
A clinical study on conjunctival malignant melanoma
Region
| Japan |
Condition
Condition
Conjunctival malignant melanoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to analyze clinical course, contents of treatments and distant metastasis in biopsy-proven conjunctival melanoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Contents of treatments, presence of distant metastasis one month, 6, 12, 24, 36 months after initial presentation
Key secondary outcomes
if globe was preserved, changing of slit-lamp examination findings
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
Biopsy-proven conjunctival melanoma cases
Key exclusion criteria
Conjunctival nevus/melanosis
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Kase |
Organization
Hokkaido University
Division name
Ophthalmology
Zip code
Address
Sapporo city, N14 W5
TEL
011-706-5944
kaseron@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Kase |
Organization
Hokkaido University
Division name
Ophthalmology
Zip code
Address
Sapporo city, N14 W5
TEL
011-706-5944
Homepage URL
kaseron@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
one patient developed distant metastasis
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 | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 22 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 22 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 01 | Day |
Other
Other related information
5 biopsy-proven conjunctival melanoma cases are enrolled
Management information
Registered date
| 2017 | Year | 02 | Month | 26 | Day |
Last modified on
| 2018 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030220
| Research Plan | |
|---|---|
| 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 |
