UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039011
Receipt number R000044488
Scientific Title Development and validation of the AI-based diagnosis system for pathological findings in invasive front of colorectal cancer
Date of disclosure of the study information 2020/02/01
Last modified on 2023/01/02 13:06:19

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Basic information

Public title

Development and validation of the AI-based diagnosis system for pathological findings in invasive front of colorectal cancer

Acronym

AI-based pathological diagnosis system for colorectal cancer

Scientific Title

Development and validation of the AI-based diagnosis system for pathological findings in invasive front of colorectal cancer

Scientific Title:Acronym

AI-based pathological diagnosis system for colorectal cancer

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To develop and validate an AI-based diagnosis system for pathological findings in invasive front of colorectal cancer, i.e. tumor budding (BD) and poorly differentiated cluster (PDC).

Basic objectives2

Others

Basic objectives -Others

To develop and validate an AI-based diagnosis system using endoscopically or surgically resected specimens from colorectal cancer patients.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Accuracy of models (i.e. dice coefficient, Jaccard Index)

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

1) Cohort 1_study cohort
Patients received curative resection
of pT1 colorectal adenocarcinoma between Jan. 2011 and Dec. 2013 in National Defense Medical Collage (NDMC).

2) Cohort 2_validation cohort
i. Patients received curative resection of pT1 colorectal adenocarcinoma between Jan. 2007 and Dec. 2008 in NDMC and Tokyo Medical and Dental University (TMDU).
ii. Patients received curative resection of pT1 colorectal adenocarcinoma between Jan. 2008 and Dec. 2010 in NDMC.

3) Cohort 3_exploratory cohort
Patients received curative resection of pStage II-III colorectal adenocarcinoma between Jan. 2007 and Dec. 2008 in NDMC and TMDU.

Key exclusion criteria

1) Appendiceal cancer
2) Not adenocarcinoma
3) Inflammatory bowel disease
4) Familial adenomatous polyposis
5) Synchronous or metachronous Multiple colorectal cancer (>pT1)
6) Synchronous or metachronous active malignancies

Target sample size

450


Research contact person

Name of lead principal investigator

1st name Megumi
Middle name
Last name ISHIGURO

Organization

Tokyo Medical and Dental University

Division name

Medical Innovation Promotion Center

Zip code

113-8519

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, JAPAN

TEL

03-5803-4730

Email

ishi.srg2@tmd.ac.jp


Public contact

Name of contact person

1st name Megumi
Middle name
Last name ISHIGURO

Organization

Tokyo Medical and Dental University

Division name

Medical Innovation Promotion Center,

Zip code

113-8519

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, JAPAN

TEL

03-5803-4730

Homepage URL


Email

ishiguro.srg2@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental University

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

Tokyo Medical and Dental University, Ethical Review Committee

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, JAPAN

Tel

03-5803-5096

Email

syomu1.adm@tmd.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

東京医科歯科大学(東京都)、防衛医科大学校(埼玉県)、東京大学(東京都)、東京慈恵会医科大学(東京都)、国立病院機構埼玉病院(埼玉県)


Other administrative information

Date of disclosure of the study information

2020 Year 02 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

Enrolling by invitation

Date of protocol fixation

2019 Year 01 Month 23 Day

Date of IRB

2020 Year 01 Month 22 Day

Anticipated trial start date

2020 Year 02 Month 01 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

2024 Year 12 Month 31 Day


Other

Other related information

To develop and validate an AI-based diagnosis system using endoscopically or surgically resected specimens from colorectal cancer patients.


Management information

Registered date

2019 Year 12 Month 26 Day

Last modified on

2023 Year 01 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044488


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name