UMIN-CTR Clinical Trial

Basic information
Public title	Risk Factors for Lymph Node Metastasis of Colorectal T2 Cancer and Prediction Model for Metastasis Using Virtual Slides
Acronym	Risk Factors for Lymph Node Metastasis of Colorectal T2 Cancer and Prediction Model for Metastasis Using Virtual Slides
Scientific Title	Risk Factors for Lymph Node Metastasis of Colorectal T2 Cancer and Prediction Model for Metastasis Using Virtual Slides
Scientific Title:Acronym	Risk Factors for Lymph Node Metastasis of Colorectal T2 Cancer and Prediction Model for Metastasis Using Virtual Slides
Region	Japan

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

Objectives
Narrative objectives1	Extraction of Risk Factors for Lymph Node Metastasis in Colorectal T2 Cancer. Construction of Artificial Intelligence to Predict Lymph Node Metastasis from Pathological Images.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic ability (sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and area under the curve) for 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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Surgical resected colon tumor
Key exclusion criteria	Cases with difficult pathological evaluation
Target sample size	700

Research contact person
Name of lead principal investigator	1st name Yuta Middle name Last name Kouyama
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	224-8503
Address	35-1, Chigasakityuo, Tsuzuki-ku, Yokohama-shi, Kanagawa-ken, Japan
TEL	045-949-7000
Email	kouyuta1101@yahoo.co.jp

Public contact
Name of contact person	1st name Yuta Middle name Last name Kouyama
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	224-8503
Address	35-1, Chigasakityuo, Tsuzuki-ku, Yokohama-shi, Kanagawa-ken, Japan
TEL	045-949-7000
Homepage URL
Email	kouyuta1101@yahoo.co.jp

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

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Showa University
Address	1-5-8, hatanodai, Shinagawa-ku, Tokyo, Japan
Tel	03-3784-8000
Email	m-rinri@ofc.showa-u.ac.jp

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	2022 Year 10 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	2022 Year 06 Month 30 Day
Date of IRB	2022 Year 07 Month 21 Day
Anticipated trial start date	2022 Year 07 Month 21 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Accumulating pathological preparation images, and constructing AI.

Management information
Registered date	2022 Year 08 Month 10 Day
Last modified on	2022 Year 08 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055393