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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024410
Receipt No. R000028083
Scientific Title Epidemiological study on incidence, stage at diagnosis, treatment and prognosis of Merkel cell carcinoma in Japan
Date of disclosure of the study information 2016/10/14
Last modified on 2016/10/14

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Basic information
Public title Epidemiological study on incidence, stage at diagnosis, treatment and prognosis of Merkel cell carcinoma in Japan
Acronym Epidemiological study of Merkel cell carcinoma in Japan
Scientific Title Epidemiological study on incidence, stage at diagnosis, treatment and prognosis of Merkel cell carcinoma in Japan
Scientific Title:Acronym Epidemiological study of Merkel cell carcinoma in Japan
Region
Japan

Condition
Condition Merkel cell carcinoma
Classification by specialty
Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study is conducted to determine the current status of treatment plan and prognosis of Merkel cell carcinoma in Japan
Basic objectives2 Others
Basic objectives -Others Epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prognosis of Merkel cell carcinoma
Key secondary outcomes The number of patients, stage at diagnosis and types of treatments of Merkel cell carcinoma

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients diagnosed with histologically confirmed Merkel cell carcinoma between January, 2005 and December, 2014 in Japan
Key exclusion criteria None
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Narisawa
Organization Saga University
Division name Division of Dermatology, Department of Internal Medicine
Zip code
Address 5-1-1 Nabeshima, Saga, Saga 849-8501, Japan
TEL 0952-34-2368
Email narisawa@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kotaro Nagase
Organization Saga University
Division name Division of Dermatology, Department of Internal Medicine
Zip code
Address 5-1-1 Nabeshima, Saga, Saga 849-8501, Japan
TEL 0952-34-2368
Homepage URL
Email nagasek@cc.saga-u.ac.jp

Sponsor
Institute Saga University
Institute
Department

Funding Source
Organization Saga University
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 10 Month 14 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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2016 Year 10 Month 14 Day
Last modified on
2016 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028083

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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