UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047431 |
|---|---|
| Receipt number | R000054088 |
| Scientific Title | Immune checkpoint inhibitors for ocular melanoma |
| Date of disclosure of the study information | 2022/04/07 |
| Last modified on | 2024/04/03 14:06:25 |
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Basic information
Public title
Immune checkpoint inhibitors for ocular melanoma
Acronym
Immune checkpoint inhibitors for ocular melanoma
Scientific Title
Immune checkpoint inhibitors for ocular melanoma
Scientific Title:Acronym
Immune checkpoint inhibitors for ocular melanoma
Region
| Japan |
Condition
Condition
Ocular melanoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate ORR, DCR, PFS, and OS among patients with ocular melanoma who were treated with ICI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ORR, DCR, PFS, and OS among patients with ocular melanoma who were treated with ICI.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with ocular melanoma who were treated with ICI
Key exclusion criteria
Patients with ocular melanoma who were treated with ICI as adjuvant/neoadjuvant therapy
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Horita |
Organization
Yokohama City University Hospital
Division name
Chemotherapy Center
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa, Yokohama
TEL
045-787-2800
horitano@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Horita |
Organization
Yokohama City University Hospital
Division name
Chemotherapy Center
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa, Yokohama
TEL
045-787-2800
Homepage URL
horitano@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital
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
Yokohama City University Hospital
Address
3-9, Fukuura, Kanazawa, Yokohama
Tel
045-787-2800
horitano@yokohama-cu.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 | 04 | Month | 07 | 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
Main results already published
Date of protocol fixation
| 2022 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Only English full article will be eligible.
Random-model meta-analysis with generic inverse variance will be conducted to pool the data.
Management information
Registered date
| 2022 | Year | 04 | Month | 07 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054088
