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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023195
Receipt No. 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 2017/01/23

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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
Middle name
Last name Yuki Yamamoto
Organization Wakayama Medical University
Division name Depertment of Dermatology
Zip code
Address 811-1 Kimiidera, Wakayama, 641-0012, Japan
TEL 073-441-0661
Email yukiy@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisako Okuhira
Organization Wakayama Medical University
Division name Depertment of Dermatology
Zip code
Address 811-1 Kimiidera, Wakayama, 641-0012, Japan
TEL 073-441-0661
Homepage URL
Email okuhisa@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
Address
Tel
Email

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
Date of protocol fixation
2015 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 14 Day
Last follow-up date
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
2017 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026582

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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