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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038257
Receipt No. R000043266
Scientific Title Prediction of lymph node metastasis in colorectal T2 cancer using artificial intelligence
Date of disclosure of the study information 2019/11/01
Last modified on 2019/10/09

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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 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
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
Date trial data considered complete
Date analysis concluded

Other
Other related information none

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


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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