UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study to evaluate indication of endoscopic therapies for early colon cancer based on the colon cancer database
Title of the study (Brief title)	Study to evaluate indication of endoscopic therapies for early colon cancer
Region	Japan

Condition
Condition	Colonic cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the correlation between the pathological findings and lymph node metastasis of early colon cancer from a database of histopathological findings of early colon cancer treatment, and to re-examine the adaptation of endoscopic treatment of early colon cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Lymph node metastasis rate in early stage colon cancer
Key secondary outcomes	The positive rate of tumor cells in the immunostaining, vascular invasion rate, relationship between the results of protein expression including the mucus trait and the pathological factors, relationship between the prognosis and pathological factors, metastatic recurrence rate, and disease-free period

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	1) Cases which was performed endoscopic resection or surgical operation for early colonic cancer pathologically diagnosed between January 2000 to research approval date. 2) Cases obtained informed consent who will be performed endoscopic resection or surgical operation for early colonic cancer pathologically diagnosed between research approval date to March 2017.
Key exclusion criteria	Cases which can not be obtained informed consent, and which had been diagnosed with adenoma or advanced cancer in the pathological diagnosis.
Target sample size	1000

Research contact person
Name of lead principal investigator	Yoshinao Oda
Organization	Kyushu University
Division name	Department of Anatomic Pathology
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL	092-642-6061
Email	oda@surgpath.med.kyushu-u.ac.jp

Public contact
Name of contact person	Tomohiko Moriyama, Minako Hirahashi, Yuta Fuyuno
Organization	Kyushu University
Division name	Department of Medicine and Clinical Science
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL	092-642-5261
Homepage URL
Email	yfuyuno@intmed2.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

Funding Source
Organization	Kyushu University
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	2016 Year 02 Month 18 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 12 Month 14 Day
Anticipated trial start date	2012 Year 12 Month 14 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	This study is single center cohort study to evaluate the histopathological characteristics for early colonic cancer.

Management information
Registered date	2016 Year 02 Month 18 Day
Last modified on	2018 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024320