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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020839
Receipt No. R000024025
Scientific Title Investigation of the actual conditions of Cowden disease
Date of disclosure of the study information 2016/02/01
Last modified on 2016/02/11

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Basic information
Public title Investigation of the actual conditions of Cowden disease
Acronym Investigation of the actual conditions of Cowden disease
Scientific Title Investigation of the actual conditions of Cowden disease
Scientific Title:Acronym Investigation of the actual conditions of Cowden disease
Region
Japan

Condition
Condition Cowden disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Our purpose is to do a questionnaire survey of Cowden disease targeted for the medical facility in Japan and to investigate an actual condition of this disease.
Basic objectives2 Others
Basic objectives -Others Investigate an actual condition
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes An actual condition of Cowden disease.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria A person with Cowden disease
Key exclusion criteria none
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuji Takayama
Organization Tokushima University Graduate School, The Institute of Biomedical Sciences, Department of Gastroenterology and Oncology
Division name Gastroenterology and Oncology
Zip code
Address 3-18-15,Kuramoto-cho, Tokushima city
TEL 088-633-7122
Email takayama@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Teramae
Organization Tokushima University Graduate School, The Institute of Biomedical Sciences
Division name Gastroenterology and Oncology
Zip code
Address 3-18-15,Kuramoto-cho, Tokushima city
TEL 088-633-7122
Homepage URL
Email wj6zahyt@yahoo.co.jp

Sponsor
Institute Tokushima University Hospital, Department of Gastroenterology and Oncology
Institute
Department

Funding Source
Organization Tokushima University Hospital, Department of Gastroenterology and Oncology
Organization
Division
Category of Funding Organization Non profit foundation
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 02 Month 01 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 Preinitiation
Date of protocol fixation
2016 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study (case-control study)

To do a questionnaire survey of Cowden disease targeted for the medical facility in Japan.
We send questionnaire in February, 2016, and add up the data until March, 2016.
The target patient is a person with Cowden disease visiting a hospital for treatment in medical facilities.

Survey Contents
Age sex accompanied disease

Management information
Registered date
2016 Year 02 Month 01 Day
Last modified on
2016 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024025

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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