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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025142
Receipt No. R000028914
Scientific Title Analysis of clinicopathologic characteristics, carcinogenic mechanisms and genetic abnormality in colorectal tumors with MSI including Lynch syndrome.
Date of disclosure of the study information 2017/01/01
Last modified on 2016/12/05

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Basic information
Public title Analysis of clinicopathologic characteristics, carcinogenic mechanisms and genetic abnormality in colorectal tumors with MSI including Lynch syndrome.
Acronym Analysis of colorectal tumors with MSI including Lynch syndrome.
Scientific Title Analysis of clinicopathologic characteristics, carcinogenic mechanisms and genetic abnormality in colorectal tumors with MSI including Lynch syndrome.
Scientific Title:Acronym Analysis of colorectal tumors with MSI including Lynch syndrome.
Region
Japan

Condition
Condition Lynch syndrome
Colorectal tumor
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To analyze clinicopathologic characteristics, carcinogenic mechanisms and genetic abnormality in colorectal tumors with MSI including Lynch syndrome.
Basic objectives2 Others
Basic objectives -Others Investigate an actual condition
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinicopathologic characteristics, carcinogenic mechanisms and genetic abnormality in colorectal tumors with MSI including Lynch syndrome.
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

Not applicable
Gender Male and Female
Key inclusion criteria Lynch syndrome patients who meet the Amsterdam criteria and the revised Bethesda guidelines.
Key exclusion criteria none
Target sample size 20

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, Kyramoto-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 Fumika Nakamura
Organization Tokushima University Graduate School, The Institute of Biomedical Sciences, Department of Gastroente
Division name Gastroenterology and Oncology
Zip code
Address 3-18-15, Kyramoto-cho, Tokushima city
TEL 088-633-7122
Homepage URL
Email fumiofumio@hotmail.com

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
2017 Year 01 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 12 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information clinicopathologic characteristics, carcinogenic mechanisms and genetic abnormality in colorectal tumors with MSI including Lynch syndrome

Management information
Registered date
2016 Year 12 Month 05 Day
Last modified on
2016 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028914

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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