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 | 2025/01/14 08:00:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
Institute of Science Tokyo
Division name
Health Science Research and Development Center
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, JAPAN
TEL
03-5803-4730
ishi.srg2@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | ISHIGURO |
Organization
Institute of Science Tokyo
Division name
Health Science Research and Development Center
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, JAPAN
TEL
03-5803-4730
Homepage URL
ishiguro.srg2@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
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
Institute of Science Tokyo, Ethical Review Committee
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, JAPAN
Tel
03-5803-4547
rinri.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
東京科学大学（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
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | 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
| 2025 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044488
