UMIN-CTR Clinical Trial

Basic information
Public title	Prediction of lymph node metastasis in colorectal T2 cancer using artificial intelligence
Acronym	Prediction of lymph node metastasis in colorectal T2 cancer using artificial intelligence
Scientific Title	Prediction of lymph node metastasis in colorectal T2 cancer using artificial intelligence
Scientific Title:Acronym	Prediction of lymph node metastasis in colorectal T2 cancer using artificial intelligence
Region	Japan

Condition
Condition	T2 colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To develop lymph node metastasis prediction software using artificial intelligence in order to identify cases that do not require lymph node dissection in T2 colorectal cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ability to predict lymph node metastasis in T2 colorectal cancer.
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	Cases of surgically resected T2 colorectal cancer that can be histologically diagnosed presense of lymph node metastasis.
Key exclusion criteria	Preoperative treatment. Patients who have not undergone lymph node dissection with local treatment alone. Double cancer. Multiple cancer. Hereditary colorectal cancer. Colitic cancer.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Kenta Middle name Last name Nakahara
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive disease center
Zip code	224-8503
Address	35-1 Chigasaki Chuo, Tsuzuki Ward, Yokohama City, Kanagawa Prefecture
TEL	0459497000
Email	ke_nakahara@yahoo.co.jp

Public contact
Name of contact person	1st name Kenta Middle name Last name Nakahara
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive disease center
Zip code	224-8503
Address	35 1Chigasaki Chuo,Tsuzuki Ward,Yokohama City,Kanagawa Prefecture
TEL	0459497000
Homepage URL
Email	ke_nakahara@yahoo.co.jp

Sponsor
Institute	Showa University Northern Yokohama 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	Showa University Northern Yokohama Hospital
Address	35 1Chigasaki Chuo,Tsuzuki Ward,Yokohama City,Kanagawa Prefecture
Tel	0459497000
Email	ke_nakahara@yahoo.co.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	2019 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2019 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2020 Year 10 Month 01 Day
Date of closure to data entry	2020 Year 10 Month 01 Day
Date trial data considered complete	2020 Year 12 Month 31 Day
Date analysis concluded	2020 Year 12 Month 31 Day

Other
Other related information	none

Management information
Registered date	2019 Year 10 Month 09 Day
Last modified on	2021 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043266