UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinicopathological features of T1 colorectal carcinomas with skip invasion
Title of the study (Brief title)	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	yuta sato
Organization	showa university yokohama northen hospital
Division name	digestive disease center
Address	35-1, Chigasaki-Chuo Tsuzuki-ku,
TEL	0459497000
Email	hokubu@ofc.showa-u.ac.jp

Public contact
Name of contact person	yuta sato
Organization	showa university yokohama northen hospital
Division name	digestive disease center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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