UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Predictive model of lymph node metastasis in T1 colorectal cancer using artificial intelligence
Title of the study (Brief title)	Predictive model of lymph node metastasis in T1 colorectal cancer using artificial intelligence
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To develop a high-quality prediction model of lymph node metastasis in T1 colorectal cancer using artificial intelligence
Basic objectives2	Others
Basic objectives -Others	To evaluate the value of a support vector machine model in the prediction of lymph node metastasis in T1 colorectal cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The presence of lymph node metastasis
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	1.Patients who received complete treatment for submucosal invasive colorectal cancer with endoscopic resection or surgical resection 2.Written informed consent
Key exclusion criteria	1.Presence of synchronous or metachronous advanced colorectal cancer 2.Presence of malignant diseases in any other organs
Target sample size	600

Research contact person
Name of lead principal investigator	KATSURO ICHIMASA
Organization	Showa University Nothern Yokohama Hospital
Division name	Digestive Disease Center
Address	Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-8503, Japan.
TEL	045-949-7000
Email	ichitommy14@yahoo.co.jp

Public contact
Name of contact person	Katsuro Ichimasa
Organization	Showa University Nothern Yokohama Hospital
Division name	Digestive Disease Center
Address	Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-8503, Japan.
TEL	045-949-7000
Homepage URL
Email	ichitommy14@yahoo.co.jp

Sponsor
Institute	Digestive Disease Center, Showa University Nothern Yokohama Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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 03 Month 15 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 11 Month 16 Day
Anticipated trial start date	2016 Year 11 Month 16 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	Published
URL releasing results
Results
Other related information	Retrospective study

Management information
Registered date	2017 Year 03 Month 14 Day
Last modified on	2018 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030015