UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023195 |
|---|---|
| Receipt number | R000026582 |
| Scientific Title | effects and prognostic factors of PD-1 inhibitors on malignant melanoma |
| Date of disclosure of the study information | 2016/07/16 |
| Last modified on | 2020/09/24 15:07:26 |
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Basic information
Public title
effects and prognostic factors of PD-1 inhibitors on malignant melanoma
Acronym
effects and prognostic factors of PD-1 inhibitors on malignant melanoma
Scientific Title
effects and prognostic factors of PD-1 inhibitors on malignant melanoma
Scientific Title:Acronym
effects and prognostic factors of PD-1 inhibitors on malignant melanoma
Region
| Japan |
Condition
Condition
Malignant melanoma
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
accesment of effect and prognostic factors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood test
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
malignant melanoma with nivolumab treatment
Key exclusion criteria
no
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Yamamoto |
Organization
Wakayama Medical University
Division name
Depertment of Dermatology
Zip code
6410012
Address
811-1 Kimiidera, Wakayama, 641-0012, Japan
TEL
073-441-0661
yukiy@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hisako |
| Middle name | |
| Last name | Okuhira |
Organization
Wakayama Medical University
Division name
Depertment of Dermatology
Zip code
6410012
Address
811-1 Kimiidera, Wakayama, 641-0012, Japan
TEL
073-441-0661
Homepage URL
okuhisa@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
no
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
Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, 641-0012, Japan
Tel
073-441-0661
okuhisa@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
| 2016 | Year | 07 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2015 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In the follow-up period
Management information
Registered date
| 2016 | Year | 07 | Month | 16 | Day |
Last modified on
| 2020 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026582
