UMIN-CTR Clinical Trial

Basic information
Public title	Prediction of lymph node metastasis in T1 colorectal cancer with artificial intelligence
Acronym	AMED T1 study
Scientific Title	Prediction of lymph node metastasis in T1 colorectal cancer with artificial intelligence
Scientific Title:Acronym	AMED T1 study
Region	Japan

Condition
Condition	T1 colorectal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To develop the predicting model for lymph node metastasis of T1 colorectal cancer
Basic objectives2	Others
Basic objectives -Others	Strategy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Predictive value (sensitivity, specificity, accuracy, AUC)
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 with T1 colorectal cancer who received complete treatment for submucosal invasive colorectal cancer with endoscopic resection or surgical resection 2.Written informed consent
Key exclusion criteria	1.Lynch syndrome 2.Familial adenomatous polyposis 3.Ulcerative colitis 4.Neo adjuvant chemo- or radio-therapy 5.Synchronous invasive carcinoma
Target sample size	3500

Research contact person
Name of lead principal investigator	1st name SHIN-EI Middle name Last name KUDO
Organization	Showa University Nothern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	224-8503
Address	Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-8503, Japan.
TEL	045-949-7000
Email	kudos@med.showa-u.ac.jp

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

Sponsor
Institute	Showa University Nothern Yokohama Hospital
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Showa University Nothern Yokohama Hospital
Address	Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-8503, Japan.
Tel	045-949-7000
Email	irb02syh@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	2019 Year 11 Month 22 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	4169
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	Main results already published
Date of protocol fixation	2017 Year 10 Month 17 Day
Date of IRB	2017 Year 10 Month 25 Day
Anticipated trial start date	2017 Year 10 Month 25 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A retrospective study

Management information
Registered date	2019 Year 11 Month 18 Day
Last modified on	2020 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043857