UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038257
Receipt number 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 2021/04/12 18:54:03

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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 or person

Institute

Showa University Northern Yokohama Hospital

Institute

Department

Personal name



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

Value
https://center6.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