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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027097
Receipt No. R000031057
Scientific Title Clinicopathological features of T1 colorectal carcinomas with skip invasion
Date of disclosure of the study information 2017/04/22
Last modified on 2017/04/22

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Basic information
Public title Clinicopathological features of T1 colorectal carcinomas with skip invasion
Acronym Clinicopathological features of colorectal carcinomas with skip invasion
Scientific Title Clinicopathological features of T1 colorectal carcinomas with skip invasion
Scientific Title:Acronym Clinicopathological features of colorectal carcinomas with skip invasion
Region
Japan

Condition
Condition T1 and T2 colorectal carcinomas with skip invasion
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the clinicopathological features of T1 colorectal carcinomas with skip invasion

Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes clinicopathological facot(gender,age,location,morphology,lymphovascular invasion,tumor differentiation,lympho node metastasis) of T1 and T2 colorectal carcinomas with skip invasion
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 T1 and T2 colorectal carcinomas surgically resected between 2001 and 2015.
Key exclusion criteria none
Target sample size 1100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name yuta sato
Organization showa university yokohama northen hospital
Division name digestive disease center
Zip code
Address 35-1, Chigasaki-Chuo Tsuzuki-ku,
TEL 0459497000
Email hokubu@ofc.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name yuta sato
Organization showa university yokohama northen hospital
Division name digestive disease center
Zip code
Address 35-1, Chigasaki-Chuo Tsuzuki-ku,
TEL 08052169902
Homepage URL
Email ssteadfastness@yahoo.co.jp

Sponsor
Institute showa university yokohama northen hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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 04 Month 22 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 Completed
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 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 T1 and T2 colorectal carcinomas surgically resected between 2001 and 2015.

Management information
Registered date
2017 Year 04 Month 22 Day
Last modified on
2017 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031057

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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